Trial Outcomes & Findings for A Study of Xevinapant (Debio 1143) in Combination With Platinum-Based Chemotherapy and Standard Fractionation Intensity-Modulated Radiotherapy in Participants With Locally Advanced Squamous Cell Carcinoma of the Head and Neck, Suitable for Definitive Chemoradiotherapy (TrilynX) (NCT NCT04459715)

Last Updated: 2025-10-08

Results Overview

Event-Free Survival (EFS) as assessed by BIRC is the time from randomization to the first of: (1) Death from any cause; (2) Progression: either radiological (per RECIST v1.1) or clinical (with/without radiologic proof, assessed endoscopically); (3) Primary treatment failure prior to complete response (CR): requirement for radical salvage surgery at primary tumor site with viable tumor confirmed histologically, even without RECIST progression; (4) Relapse after CR (locoregional): including radical salvage surgery or elective neck dissection/biopsy more than equal to (\>=) 22 weeks post-randomization showing viable tumor cells regardless of radiologic status; (5) Second cancers, unless histology excludes squamous origin. Calculated via Kaplan Meier method.

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

730 participants

Primary outcome timeframe

From randomization to the earliest between any EFS event or End of Study (EOS) (up to 188 weeks and 5 days)

Results posted on

2025-10-08

Participant Flow

Participant milestones

Participant milestones
Measure	Sequence 1: Debio 1143 + CRT Participants received a combination of Debio 1143 along with Chemoradiotherapy (CRT): Radiotherapy +Cisplatin + Xevinapant (Debio 1143). Participants received 6 cycles of oral solution of Xevinapant at a dose of 200 milligrams per day (mg/day) once daily from Day 1 to 14, per 3-week cycle in combination with 70 Gray (Gy) of intensity modulated radiation therapy (IMRT) in 35 fractions, 2 Gy/fraction, over 7 weeks, and High-dose cisplatin (100 Milligram per square meter (mg/m2)) on Day 2 of a 3-week cycle per 3 cycles (combination therapy period). If high-dose cisplatin 100 mg/m2 was not tolerated after the first dose, participants could be switched to carboplatin (10 Milligrams per milliliter (mg/mL), intravenous (iv) infusion), followed by 3 cycles of monotherapy of Xevinapant at a dose of 200 mg/day from Day 1 to 14, per 3-week cycle (monotherapy period).	Sequence 2: Placebo + CRT Participants received a combination of placebo matched to Debio 1143 along with Chemoradiotherapy(CRT): Radiotherapy +Cisplatin+ placebo matched to Xevinapant (Debio 1143). Participants received 6 cycles of oral solution of placebo matched to Xevinapant once daily from Day 1 to 14, per 3-week cycle in combination with 70 Gray (Gy) of intensity modulated radiation therapy (IMRT) in 35 fractions, 2 Gy/fraction, over 7 weeks, and High-dose cisplatin (100 mg/m2) on Day 2 of a 3-week cycle per 3 cycles(combination therapy period).If high-dose cisplatin 100 mg/m2 was not tolerated after the first dose, participants could be switched to carboplatin (10mg/mL, iv infusion), followed by 3 cycles of monotherapy of placebo matched to Xevinapant from Day 1 to 14, per 3-week cycle (monotherapy period).
Overall Study STARTED	364	366
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	364	366

Reasons for withdrawal

Reasons for withdrawal
Measure	Sequence 1: Debio 1143 + CRT Participants received a combination of Debio 1143 along with Chemoradiotherapy (CRT): Radiotherapy +Cisplatin + Xevinapant (Debio 1143). Participants received 6 cycles of oral solution of Xevinapant at a dose of 200 milligrams per day (mg/day) once daily from Day 1 to 14, per 3-week cycle in combination with 70 Gray (Gy) of intensity modulated radiation therapy (IMRT) in 35 fractions, 2 Gy/fraction, over 7 weeks, and High-dose cisplatin (100 Milligram per square meter (mg/m2)) on Day 2 of a 3-week cycle per 3 cycles (combination therapy period). If high-dose cisplatin 100 mg/m2 was not tolerated after the first dose, participants could be switched to carboplatin (10 Milligrams per milliliter (mg/mL), intravenous (iv) infusion), followed by 3 cycles of monotherapy of Xevinapant at a dose of 200 mg/day from Day 1 to 14, per 3-week cycle (monotherapy period).	Sequence 2: Placebo + CRT Participants received a combination of placebo matched to Debio 1143 along with Chemoradiotherapy(CRT): Radiotherapy +Cisplatin+ placebo matched to Xevinapant (Debio 1143). Participants received 6 cycles of oral solution of placebo matched to Xevinapant once daily from Day 1 to 14, per 3-week cycle in combination with 70 Gray (Gy) of intensity modulated radiation therapy (IMRT) in 35 fractions, 2 Gy/fraction, over 7 weeks, and High-dose cisplatin (100 mg/m2) on Day 2 of a 3-week cycle per 3 cycles(combination therapy period).If high-dose cisplatin 100 mg/m2 was not tolerated after the first dose, participants could be switched to carboplatin (10mg/mL, iv infusion), followed by 3 cycles of monotherapy of placebo matched to Xevinapant from Day 1 to 14, per 3-week cycle (monotherapy period).
Overall Study Adverse Event	3	3
Overall Study Death	111	93
Overall Study Lost to Follow-up	10	9
Overall Study Other Reasons	4	5
Overall Study PROTOCOL DEVIATION	0	1
Overall Study RANDOMIZED BY MISTAKE	0	1
Overall Study STUDY TERMINATED BY SPONSOR	214	232
Overall Study Withdrawal by Subject	22	22

Baseline Characteristics

A Study of Xevinapant (Debio 1143) in Combination With Platinum-Based Chemotherapy and Standard Fractionation Intensity-Modulated Radiotherapy in Participants With Locally Advanced Squamous Cell Carcinoma of the Head and Neck, Suitable for Definitive Chemoradiotherapy (TrilynX)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sequence 1: Debio 1143 + CRT n=364 Participants Participants received a combination of Debio 1143 along with Chemoradiotherapy (CRT): Radiotherapy +Cisplatin + Xevinapant (Debio 1143). Participants received 6 cycles of oral solution of Xevinapant at a dose of 200 milligrams per day (mg/day) once daily from Day 1 to 14, per 3-week cycle in combination with 70 Gray (Gy) of intensity modulated radiation therapy (IMRT) in 35 fractions, 2 Gy/fraction, over 7 weeks, and High-dose cisplatin (100 mg/m2) on Day 2 of a 3-week cycle per 3 cycles (combination therapy period). If high-dose cisplatin 100 mg/m2 was not tolerated after the first dose, participants could be switched to carboplatin (10mg/mL, iv infusion), followed by 3 cycles of monotherapy of Xevinapant at a dose of 200 mg/day from Day 1 to 14, per 3-week cycle (monotherapy period).	Sequence 2: Placebo + CRT n=366 Participants Participants received a combination of placebo matched to Debio 1143 along with Chemoradiotherapy(CRT): Radiotherapy +Cisplatin+ placebo matched to Xevinapant (Debio 1143). Participants received 6 cycles of oral solution of placebo matched to Xevinapant once daily from Day 1 to 14, per 3-week cycle in combination with 70 Gray (Gy) of intensity modulated radiation therapy (IMRT) in 35 fractions, 2 Gy/fraction, over 7 weeks, and High-dose cisplatin (100 mg/m2) on Day 2 of a 3-week cycle per 3 cycles(combination therapy period).If high-dose cisplatin 100 mg/m2 was not tolerated after the first dose, participants could be switched to carboplatin (10mg/mL, iv infusion), followed by 3 cycles of monotherapy of placebo matched to Xevinapant from Day 1 to 14, per 3-week cycle (monotherapy period).	Total n=730 Participants Total of all reporting groups
Age, Continuous	60 Years STANDARD_DEVIATION 8.01 • n=99 Participants	60 Years STANDARD_DEVIATION 8.53 • n=107 Participants	60 Years STANDARD_DEVIATION 8.27 • n=206 Participants
Sex: Female, Male Female	64 Participants n=99 Participants	57 Participants n=107 Participants	121 Participants n=206 Participants
Sex: Female, Male Male	300 Participants n=99 Participants	309 Participants n=107 Participants	609 Participants n=206 Participants
Race/Ethnicity, Customized Ethnicity-Hispanic or Latino	41 Participants n=99 Participants	46 Participants n=107 Participants	87 Participants n=206 Participants
Race/Ethnicity, Customized Ethnicity-Not Hispanic or Latino	264 Participants n=99 Participants	273 Participants n=107 Participants	537 Participants n=206 Participants
Race/Ethnicity, Customized Ethnicity-Unknown or Not Reported	59 Participants n=99 Participants	47 Participants n=107 Participants	106 Participants n=206 Participants
Race/Ethnicity, Customized Race-Asian	59 Participants n=99 Participants	60 Participants n=107 Participants	119 Participants n=206 Participants
Race/Ethnicity, Customized Race-Black or African American	5 Participants n=99 Participants	6 Participants n=107 Participants	11 Participants n=206 Participants
Race/Ethnicity, Customized Race-Other	5 Participants n=99 Participants	9 Participants n=107 Participants	14 Participants n=206 Participants
Race/Ethnicity, Customized Race-Unknown or Not Reported	42 Participants n=99 Participants	35 Participants n=107 Participants	77 Participants n=206 Participants
Race/Ethnicity, Customized Race-White	253 Participants n=99 Participants	256 Participants n=107 Participants	509 Participants n=206 Participants

PRIMARY outcome

Timeframe: From randomization to the earliest between any EFS event or End of Study (EOS) (up to 188 weeks and 5 days)

Population: The Intention To Treat (ITT) set included all randomized participants.

Outcome measures

Outcome measures
Measure	Sequence 1: Debio 1143 + CRT n=364 Participants Participants received a combination of Debio 1143 along with Chemoradiotherapy (CRT): Radiotherapy +Cisplatin + Xevinapant (Debio 1143). Participants received 6 cycles of oral solution of Xevinapant at a dose of 200 milligrams per day (mg/day) once daily from Day 1 to 14, per 3-week cycle in combination with 70 Gray (Gy) of intensity modulated radiation therapy (IMRT) in 35 fractions, 2 Gy/fraction, over 7 weeks, and High-dose cisplatin (100 mg/m2) on Day 2 of a 3-week cycle per 3 cycles (combination therapy period). If high-dose cisplatin 100 mg/m2 was not tolerated after the first dose, participants could be switched to carboplatin (10mg/mL, iv infusion), followed by 3 cycles of monotherapy of Xevinapant at a dose of 200 mg/day from Day 1 to 14, per 3-week cycle (monotherapy period).	Sequence 2: Placebo + CRT n=366 Participants Participants received a combination of placebo matched to Debio 1143 along with Chemoradiotherapy(CRT): Radiotherapy +Cisplatin+ placebo matched to Xevinapant (Debio 1143). Participants received 6 cycles of oral solution of placebo matched to Xevinapant once daily from Day 1 to 14, per 3-week cycle in combination with 70 Gray (Gy) of intensity modulated radiation therapy (IMRT) in 35 fractions, 2 Gy/fraction, over 7 weeks, and High-dose cisplatin (100 mg/m2) on Day 2 of a 3-week cycle per 3 cycles(combination therapy period).If high-dose cisplatin 100 mg/m2 was not tolerated after the first dose, participants could be switched to carboplatin (10mg/mL, iv infusion), followed by 3 cycles of monotherapy of placebo matched to Xevinapant from Day 1 to 14, per 3-week cycle (monotherapy period).
Event-Free Survival (EFS) as Assessed by Blinded Independent Review Committee (BIRC)	19.4 months Interval 14.46 to Due to the limited number of events, the upper limit of the 95% CI for the median could not be derived.	33.1 months Interval 20.99 to Due to the limited number of events, the upper limit of the 95% CI for the median could not be derived.

SECONDARY outcome

Timeframe: From randomization to the earliest between death or EOS (up to 188 weeks and 5 days)

Population: The ITT set included all randomized participants. Participants were analyzed according to the randomized treatment (assigned arm) assignment following the intention-to-treat principle.

Overall survival is defined as the time from randomization to the date of death. Calculated via Kaplan Meier method.

Outcome measures

Outcome measures
Measure	Sequence 1: Debio 1143 + CRT n=364 Participants Participants received a combination of Debio 1143 along with Chemoradiotherapy (CRT): Radiotherapy +Cisplatin + Xevinapant (Debio 1143). Participants received 6 cycles of oral solution of Xevinapant at a dose of 200 milligrams per day (mg/day) once daily from Day 1 to 14, per 3-week cycle in combination with 70 Gray (Gy) of intensity modulated radiation therapy (IMRT) in 35 fractions, 2 Gy/fraction, over 7 weeks, and High-dose cisplatin (100 mg/m2) on Day 2 of a 3-week cycle per 3 cycles (combination therapy period). If high-dose cisplatin 100 mg/m2 was not tolerated after the first dose, participants could be switched to carboplatin (10mg/mL, iv infusion), followed by 3 cycles of monotherapy of Xevinapant at a dose of 200 mg/day from Day 1 to 14, per 3-week cycle (monotherapy period).	Sequence 2: Placebo + CRT n=366 Participants Participants received a combination of placebo matched to Debio 1143 along with Chemoradiotherapy(CRT): Radiotherapy +Cisplatin+ placebo matched to Xevinapant (Debio 1143). Participants received 6 cycles of oral solution of placebo matched to Xevinapant once daily from Day 1 to 14, per 3-week cycle in combination with 70 Gray (Gy) of intensity modulated radiation therapy (IMRT) in 35 fractions, 2 Gy/fraction, over 7 weeks, and High-dose cisplatin (100 mg/m2) on Day 2 of a 3-week cycle per 3 cycles(combination therapy period).If high-dose cisplatin 100 mg/m2 was not tolerated after the first dose, participants could be switched to carboplatin (10mg/mL, iv infusion), followed by 3 cycles of monotherapy of placebo matched to Xevinapant from Day 1 to 14, per 3-week cycle (monotherapy period).
Overall Survival (OS)	NA months Interval 0.0 to 37.6 Due to the limited number of events, the median could not be derived.	NA months Interval 0.0 to 39.4 Due to the limited number of events, the median could not be derived.

SECONDARY outcome

Timeframe: From randomization to the first occurrence of progression (radiological or clinical, as assessed by the BIRC) or death from any cause or EOS (up to 188 weeks and 5 days )

Population: The ITT set included all randomized participants. Participants were analyzed according to the randomized treatment (assigned arm) assignment following the intention-to-treat principle.

PFS according to RECIST v1.1 defined as the time from randomization to the first occurrence of progression (radiological or clinical, as assessed by the BIRC) or death from any cause. According to RECIST 1.1, progressive disease (PD) was defined as a 20% relative increase in the sum of diameters (SOD) of target lesions, taking as reference the nadir SOD and an absolute increase of \>5 millimeter (mm) in the SOD, or the appearance of new lesions. Calculated via Kaplan Meier method.

Outcome measures

Outcome measures
Measure	Sequence 1: Debio 1143 + CRT n=364 Participants Participants received a combination of Debio 1143 along with Chemoradiotherapy (CRT): Radiotherapy +Cisplatin + Xevinapant (Debio 1143). Participants received 6 cycles of oral solution of Xevinapant at a dose of 200 milligrams per day (mg/day) once daily from Day 1 to 14, per 3-week cycle in combination with 70 Gray (Gy) of intensity modulated radiation therapy (IMRT) in 35 fractions, 2 Gy/fraction, over 7 weeks, and High-dose cisplatin (100 mg/m2) on Day 2 of a 3-week cycle per 3 cycles (combination therapy period). If high-dose cisplatin 100 mg/m2 was not tolerated after the first dose, participants could be switched to carboplatin (10mg/mL, iv infusion), followed by 3 cycles of monotherapy of Xevinapant at a dose of 200 mg/day from Day 1 to 14, per 3-week cycle (monotherapy period).	Sequence 2: Placebo + CRT n=366 Participants Participants received a combination of placebo matched to Debio 1143 along with Chemoradiotherapy(CRT): Radiotherapy +Cisplatin+ placebo matched to Xevinapant (Debio 1143). Participants received 6 cycles of oral solution of placebo matched to Xevinapant once daily from Day 1 to 14, per 3-week cycle in combination with 70 Gray (Gy) of intensity modulated radiation therapy (IMRT) in 35 fractions, 2 Gy/fraction, over 7 weeks, and High-dose cisplatin (100 mg/m2) on Day 2 of a 3-week cycle per 3 cycles(combination therapy period).If high-dose cisplatin 100 mg/m2 was not tolerated after the first dose, participants could be switched to carboplatin (10mg/mL, iv infusion), followed by 3 cycles of monotherapy of placebo matched to Xevinapant from Day 1 to 14, per 3-week cycle (monotherapy period).
Progression Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as Assessed by Blinded Independent Review Committee (BIRC)	26.8 months Interval 15.93 to Due to the limited number of events, the upper limit of the 95% CI for the median could not be derived.	33.1 months Interval 22.83 to Due to the limited number of events, the upper limit of the 95% CI for the median could not be derived.

SECONDARY outcome

Timeframe: From randomization to the first occurrence of progression at the site of the primary tumor or the locoregional lymph nodes or End Of Study (EOS) (188 weeks and 5 days)

Population: The ITT set included all randomized participants. Participants were analyzed according to the randomized treatment (assigned arm) assignment following the intention-to-treat principle.

LRC time is defined as the time from randomization to the first occurrence of progression at the site of the primary tumor or the locoregional lymph nodes, either according to RECIST v1.1 or based on clinical assessment (radiological or clinical, as assessed by the Investigator). According to RECIST 1.1, progressive disease (PD) was defined as a 20% relative increase in the sum of diameters (SOD) of target lesions, taking as reference the nadir SOD and an absolute increase of \>5 millimeter (mm) in the SOD, or the appearance of new lesions. Calculated via Kaplan Meier method.

Outcome measures

Outcome measures
Measure	Sequence 1: Debio 1143 + CRT n=364 Participants Participants received a combination of Debio 1143 along with Chemoradiotherapy (CRT): Radiotherapy +Cisplatin + Xevinapant (Debio 1143). Participants received 6 cycles of oral solution of Xevinapant at a dose of 200 milligrams per day (mg/day) once daily from Day 1 to 14, per 3-week cycle in combination with 70 Gray (Gy) of intensity modulated radiation therapy (IMRT) in 35 fractions, 2 Gy/fraction, over 7 weeks, and High-dose cisplatin (100 mg/m2) on Day 2 of a 3-week cycle per 3 cycles (combination therapy period). If high-dose cisplatin 100 mg/m2 was not tolerated after the first dose, participants could be switched to carboplatin (10mg/mL, iv infusion), followed by 3 cycles of monotherapy of Xevinapant at a dose of 200 mg/day from Day 1 to 14, per 3-week cycle (monotherapy period).	Sequence 2: Placebo + CRT n=366 Participants Participants received a combination of placebo matched to Debio 1143 along with Chemoradiotherapy(CRT): Radiotherapy +Cisplatin+ placebo matched to Xevinapant (Debio 1143). Participants received 6 cycles of oral solution of placebo matched to Xevinapant once daily from Day 1 to 14, per 3-week cycle in combination with 70 Gray (Gy) of intensity modulated radiation therapy (IMRT) in 35 fractions, 2 Gy/fraction, over 7 weeks, and High-dose cisplatin (100 mg/m2) on Day 2 of a 3-week cycle per 3 cycles(combination therapy period).If high-dose cisplatin 100 mg/m2 was not tolerated after the first dose, participants could be switched to carboplatin (10mg/mL, iv infusion), followed by 3 cycles of monotherapy of placebo matched to Xevinapant from Day 1 to 14, per 3-week cycle (monotherapy period).
Locoregional Control (LRC) Time	NA months Interval 0.0 to 37.0 Due to the limited number of events, the median could not be derived.	NA months Interval 0.0 to 38.2 Due to the limited number of events, the median could not be derived.

SECONDARY outcome

Timeframe: At 9 and 12 months post randomization

Population: The ITT set included all randomized participants. Participants were analyzed according to the randomized treatment (assigned arm) assignment following the intention-to-treat principle.

Objective response rate was defined as percentage of participants with either a confirmed complete response (CR) or partial response (PR). CR: Disappearance of all target and non-target lesions. PR: At least a 30 percent (%) decrease in the sum of diameters of target lesions, taking as reference the baseline sum of their diameters, and no unequivocal progression of non-target lesions. Progression is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on the study, or unequivocal progression of non-target lesions, or appearance of any new lesion.

Outcome measures

Outcome measures
Measure	Sequence 1: Debio 1143 + CRT n=364 Participants Participants received a combination of Debio 1143 along with Chemoradiotherapy (CRT): Radiotherapy +Cisplatin + Xevinapant (Debio 1143). Participants received 6 cycles of oral solution of Xevinapant at a dose of 200 milligrams per day (mg/day) once daily from Day 1 to 14, per 3-week cycle in combination with 70 Gray (Gy) of intensity modulated radiation therapy (IMRT) in 35 fractions, 2 Gy/fraction, over 7 weeks, and High-dose cisplatin (100 mg/m2) on Day 2 of a 3-week cycle per 3 cycles (combination therapy period). If high-dose cisplatin 100 mg/m2 was not tolerated after the first dose, participants could be switched to carboplatin (10mg/mL, iv infusion), followed by 3 cycles of monotherapy of Xevinapant at a dose of 200 mg/day from Day 1 to 14, per 3-week cycle (monotherapy period).	Sequence 2: Placebo + CRT n=366 Participants Participants received a combination of placebo matched to Debio 1143 along with Chemoradiotherapy(CRT): Radiotherapy +Cisplatin+ placebo matched to Xevinapant (Debio 1143). Participants received 6 cycles of oral solution of placebo matched to Xevinapant once daily from Day 1 to 14, per 3-week cycle in combination with 70 Gray (Gy) of intensity modulated radiation therapy (IMRT) in 35 fractions, 2 Gy/fraction, over 7 weeks, and High-dose cisplatin (100 mg/m2) on Day 2 of a 3-week cycle per 3 cycles(combination therapy period).If high-dose cisplatin 100 mg/m2 was not tolerated after the first dose, participants could be switched to carboplatin (10mg/mL, iv infusion), followed by 3 cycles of monotherapy of placebo matched to Xevinapant from Day 1 to 14, per 3-week cycle (monotherapy period).
Objective Response Rate (ORR) as Assessed by BIRC 9 Months Post Randomization	73.4 percentage of participants	77.3 percentage of participants
Objective Response Rate (ORR) as Assessed by BIRC 12 Months Post Randomization	73.6 percentage of participants	77.9 percentage of participants

SECONDARY outcome

Timeframe: At 9 and 12 months post randomization

Population: The ITT set included all randomized participants. Participants were analyzed according to the randomized treatment (assigned arm) assignment following the intention-to-treat principle.

CRR defined as the number of participants with Complete Response by RECIST v1.1, as assessed by the BIRC. Complete response is defined as disappearance of all target and non-target lesions.

Outcome measures

Outcome measures
Measure	Sequence 1: Debio 1143 + CRT n=364 Participants Participants received a combination of Debio 1143 along with Chemoradiotherapy (CRT): Radiotherapy +Cisplatin + Xevinapant (Debio 1143). Participants received 6 cycles of oral solution of Xevinapant at a dose of 200 milligrams per day (mg/day) once daily from Day 1 to 14, per 3-week cycle in combination with 70 Gray (Gy) of intensity modulated radiation therapy (IMRT) in 35 fractions, 2 Gy/fraction, over 7 weeks, and High-dose cisplatin (100 mg/m2) on Day 2 of a 3-week cycle per 3 cycles (combination therapy period). If high-dose cisplatin 100 mg/m2 was not tolerated after the first dose, participants could be switched to carboplatin (10mg/mL, iv infusion), followed by 3 cycles of monotherapy of Xevinapant at a dose of 200 mg/day from Day 1 to 14, per 3-week cycle (monotherapy period).	Sequence 2: Placebo + CRT n=366 Participants Participants received a combination of placebo matched to Debio 1143 along with Chemoradiotherapy(CRT): Radiotherapy +Cisplatin+ placebo matched to Xevinapant (Debio 1143). Participants received 6 cycles of oral solution of placebo matched to Xevinapant once daily from Day 1 to 14, per 3-week cycle in combination with 70 Gray (Gy) of intensity modulated radiation therapy (IMRT) in 35 fractions, 2 Gy/fraction, over 7 weeks, and High-dose cisplatin (100 mg/m2) on Day 2 of a 3-week cycle per 3 cycles(combination therapy period).If high-dose cisplatin 100 mg/m2 was not tolerated after the first dose, participants could be switched to carboplatin (10mg/mL, iv infusion), followed by 3 cycles of monotherapy of placebo matched to Xevinapant from Day 1 to 14, per 3-week cycle (monotherapy period).
Complete Response Rate (CRR) 9 Months Post Randomization	187 Participants	212 Participants
Complete Response Rate (CRR) 12 Months Post Randomization	194 Participants	222 Participants

SECONDARY outcome

Timeframe: Time from first evidence of response to the first occurrence of progression or death from any cause, assessed up to 24 months

Population: The ITT set included all randomized participants. Participants were analyzed according to the randomized treatment (assigned arm) assignment following the intention-to-treat principle. "Number of participants analyzed" signifies participants who were evaluable for this outcome measure.

Duration of response (DoR) defined as the time from the first evidence of response (partial or complete, as assessed by the BIRC according to RECIST v1.1) to the first occurrence of progression (radiological or clinical, as assessed by the BIRC) or death from any cause. Kaplan Meier method was used for calculation.

Outcome measures

Outcome measures
Measure	Sequence 1: Debio 1143 + CRT n=269 Participants Participants received a combination of Debio 1143 along with Chemoradiotherapy (CRT): Radiotherapy +Cisplatin + Xevinapant (Debio 1143). Participants received 6 cycles of oral solution of Xevinapant at a dose of 200 milligrams per day (mg/day) once daily from Day 1 to 14, per 3-week cycle in combination with 70 Gray (Gy) of intensity modulated radiation therapy (IMRT) in 35 fractions, 2 Gy/fraction, over 7 weeks, and High-dose cisplatin (100 mg/m2) on Day 2 of a 3-week cycle per 3 cycles (combination therapy period). If high-dose cisplatin 100 mg/m2 was not tolerated after the first dose, participants could be switched to carboplatin (10mg/mL, iv infusion), followed by 3 cycles of monotherapy of Xevinapant at a dose of 200 mg/day from Day 1 to 14, per 3-week cycle (monotherapy period).	Sequence 2: Placebo + CRT n=287 Participants Participants received a combination of placebo matched to Debio 1143 along with Chemoradiotherapy(CRT): Radiotherapy +Cisplatin+ placebo matched to Xevinapant (Debio 1143). Participants received 6 cycles of oral solution of placebo matched to Xevinapant once daily from Day 1 to 14, per 3-week cycle in combination with 70 Gray (Gy) of intensity modulated radiation therapy (IMRT) in 35 fractions, 2 Gy/fraction, over 7 weeks, and High-dose cisplatin (100 mg/m2) on Day 2 of a 3-week cycle per 3 cycles(combination therapy period).If high-dose cisplatin 100 mg/m2 was not tolerated after the first dose, participants could be switched to carboplatin (10mg/mL, iv infusion), followed by 3 cycles of monotherapy of placebo matched to Xevinapant from Day 1 to 14, per 3-week cycle (monotherapy period).
Duration of Response (DOR)	NA months Interval 0.0 to 33.5 Due to the limited number of events, the median could not be derived.	NA months Interval 0.0 to 33.7 Due to the limited number of events, the median could not be derived.

SECONDARY outcome

Timeframe: At 9, 12, 24 and 36 months post randomization

Population: The ITT set included all randomized participants. Participants were analyzed according to the randomized treatment (assigned arm) assignment following the intention-to-treat principle.

Number of Participants with Radical Salvage Surgery (excluding elective neck dissection without anatomopathological evidence of residual malignant cells) was reported.

Outcome measures

Outcome measures
Measure	Sequence 1: Debio 1143 + CRT n=364 Participants Participants received a combination of Debio 1143 along with Chemoradiotherapy (CRT): Radiotherapy +Cisplatin + Xevinapant (Debio 1143). Participants received 6 cycles of oral solution of Xevinapant at a dose of 200 milligrams per day (mg/day) once daily from Day 1 to 14, per 3-week cycle in combination with 70 Gray (Gy) of intensity modulated radiation therapy (IMRT) in 35 fractions, 2 Gy/fraction, over 7 weeks, and High-dose cisplatin (100 mg/m2) on Day 2 of a 3-week cycle per 3 cycles (combination therapy period). If high-dose cisplatin 100 mg/m2 was not tolerated after the first dose, participants could be switched to carboplatin (10mg/mL, iv infusion), followed by 3 cycles of monotherapy of Xevinapant at a dose of 200 mg/day from Day 1 to 14, per 3-week cycle (monotherapy period).	Sequence 2: Placebo + CRT n=366 Participants Participants received a combination of placebo matched to Debio 1143 along with Chemoradiotherapy(CRT): Radiotherapy +Cisplatin+ placebo matched to Xevinapant (Debio 1143). Participants received 6 cycles of oral solution of placebo matched to Xevinapant once daily from Day 1 to 14, per 3-week cycle in combination with 70 Gray (Gy) of intensity modulated radiation therapy (IMRT) in 35 fractions, 2 Gy/fraction, over 7 weeks, and High-dose cisplatin (100 mg/m2) on Day 2 of a 3-week cycle per 3 cycles(combination therapy period).If high-dose cisplatin 100 mg/m2 was not tolerated after the first dose, participants could be switched to carboplatin (10mg/mL, iv infusion), followed by 3 cycles of monotherapy of placebo matched to Xevinapant from Day 1 to 14, per 3-week cycle (monotherapy period).
Number of Participants With Radical Salvage Surgery Month 9	10 Participants	3 Participants
Number of Participants With Radical Salvage Surgery Month 12	19 Participants	5 Participants
Number of Participants With Radical Salvage Surgery Month 24	23 Participants	9 Participants
Number of Participants With Radical Salvage Surgery Month 36	23 Participants	9 Participants

SECONDARY outcome

Timeframe: Up to 188 weeks and 5 days post randomization

Population: The ITT set included all randomized participants. Participants were analyzed according to the randomized treatment (assigned arm) assignment following the intention-to-treat principle.

Time to new subsequent systemic cancer treatment (in months) was derived as (date of event/censoring - randomization date +1) / 30.4375. Calculated via kaplan meier method.

Outcome measures

Outcome measures
Measure	Sequence 1: Debio 1143 + CRT n=364 Participants Participants received a combination of Debio 1143 along with Chemoradiotherapy (CRT): Radiotherapy +Cisplatin + Xevinapant (Debio 1143). Participants received 6 cycles of oral solution of Xevinapant at a dose of 200 milligrams per day (mg/day) once daily from Day 1 to 14, per 3-week cycle in combination with 70 Gray (Gy) of intensity modulated radiation therapy (IMRT) in 35 fractions, 2 Gy/fraction, over 7 weeks, and High-dose cisplatin (100 mg/m2) on Day 2 of a 3-week cycle per 3 cycles (combination therapy period). If high-dose cisplatin 100 mg/m2 was not tolerated after the first dose, participants could be switched to carboplatin (10mg/mL, iv infusion), followed by 3 cycles of monotherapy of Xevinapant at a dose of 200 mg/day from Day 1 to 14, per 3-week cycle (monotherapy period).	Sequence 2: Placebo + CRT n=366 Participants Participants received a combination of placebo matched to Debio 1143 along with Chemoradiotherapy(CRT): Radiotherapy +Cisplatin+ placebo matched to Xevinapant (Debio 1143). Participants received 6 cycles of oral solution of placebo matched to Xevinapant once daily from Day 1 to 14, per 3-week cycle in combination with 70 Gray (Gy) of intensity modulated radiation therapy (IMRT) in 35 fractions, 2 Gy/fraction, over 7 weeks, and High-dose cisplatin (100 mg/m2) on Day 2 of a 3-week cycle per 3 cycles(combination therapy period).If high-dose cisplatin 100 mg/m2 was not tolerated after the first dose, participants could be switched to carboplatin (10mg/mL, iv infusion), followed by 3 cycles of monotherapy of placebo matched to Xevinapant from Day 1 to 14, per 3-week cycle (monotherapy period).
Time to Subsequent Systemic Cancer Treatments	NA months Median and 95% Confidence interval (CI) could not be calculated and estimated as there were insufficient number of participants with events.	NA months Median and 95% CI could not be calculated and estimated as there were insufficient number of participants with events.

SECONDARY outcome

Timeframe: From signed informed consent to EOS (up to 188 weeks and 5 days)

Population: The safety analysis set (SAF set) included all participants who received any dose of any of the study intervention (xevinapant/matched placebo, cisplatin/carboplatin, IMRT).

An AE is any unfavorable/unintended sign (e.g., abnormal lab result), symptom or disease temporally linked to study drug, whether or not related. A serious AE leads to death, is life-threatening, causes significant/persistent disability, hospitalization, congenital anomaly, or is medically important. TEAEs include both serious and non-serious AEs after treatment. AESIs are events of clinical interest needing close monitoring. In this study, AESIs include: infusion reactions including hypersensitivity, immune-related AEs, aspartate aminotransferase/alanine transaminase increases, lipase/amylase elevation, acute renal failure, QTcF more than 30 milliseconds above baseline, and ≥Grade 2 inflammatory cutaneous AEs.

Outcome measures

Outcome measures
Measure	Sequence 1: Debio 1143 + CRT n=364 Participants Participants received a combination of Debio 1143 along with Chemoradiotherapy (CRT): Radiotherapy +Cisplatin + Xevinapant (Debio 1143). Participants received 6 cycles of oral solution of Xevinapant at a dose of 200 milligrams per day (mg/day) once daily from Day 1 to 14, per 3-week cycle in combination with 70 Gray (Gy) of intensity modulated radiation therapy (IMRT) in 35 fractions, 2 Gy/fraction, over 7 weeks, and High-dose cisplatin (100 mg/m2) on Day 2 of a 3-week cycle per 3 cycles (combination therapy period). If high-dose cisplatin 100 mg/m2 was not tolerated after the first dose, participants could be switched to carboplatin (10mg/mL, iv infusion), followed by 3 cycles of monotherapy of Xevinapant at a dose of 200 mg/day from Day 1 to 14, per 3-week cycle (monotherapy period).	Sequence 2: Placebo + CRT n=356 Participants Participants received a combination of placebo matched to Debio 1143 along with Chemoradiotherapy(CRT): Radiotherapy +Cisplatin+ placebo matched to Xevinapant (Debio 1143). Participants received 6 cycles of oral solution of placebo matched to Xevinapant once daily from Day 1 to 14, per 3-week cycle in combination with 70 Gray (Gy) of intensity modulated radiation therapy (IMRT) in 35 fractions, 2 Gy/fraction, over 7 weeks, and High-dose cisplatin (100 mg/m2) on Day 2 of a 3-week cycle per 3 cycles(combination therapy period).If high-dose cisplatin 100 mg/m2 was not tolerated after the first dose, participants could be switched to carboplatin (10mg/mL, iv infusion), followed by 3 cycles of monotherapy of placebo matched to Xevinapant from Day 1 to 14, per 3-week cycle (monotherapy period).
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, Adverse Events (AEs) of Special Interest TEAEs	362 Participants	351 Participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, Adverse Events (AEs) of Special Interest Serious TEAEs	194 Participants	129 Participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, Adverse Events (AEs) of Special Interest AESI	357 Participants	342 Participants

SECONDARY outcome

Timeframe: From signed informed consent to EOS (up to 188 weeks and 5 days)

Population: The SAF set included all participants who received any dose of any of the study intervention (xevinapant/matched placebo, cisplatin/carboplatin, IMRT).

Severity of TEAEs were evaluated using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version. The grade are as follows: grade 1 : mild grade 2 : moderate grade 3 : severe or medically significant but not immediately life-threatening grade 4 : life threatening or disabling grade 5 : death related to AE.

Outcome measures

Outcome measures
Measure	Sequence 1: Debio 1143 + CRT n=364 Participants Participants received a combination of Debio 1143 along with Chemoradiotherapy (CRT): Radiotherapy +Cisplatin + Xevinapant (Debio 1143). Participants received 6 cycles of oral solution of Xevinapant at a dose of 200 milligrams per day (mg/day) once daily from Day 1 to 14, per 3-week cycle in combination with 70 Gray (Gy) of intensity modulated radiation therapy (IMRT) in 35 fractions, 2 Gy/fraction, over 7 weeks, and High-dose cisplatin (100 mg/m2) on Day 2 of a 3-week cycle per 3 cycles (combination therapy period). If high-dose cisplatin 100 mg/m2 was not tolerated after the first dose, participants could be switched to carboplatin (10mg/mL, iv infusion), followed by 3 cycles of monotherapy of Xevinapant at a dose of 200 mg/day from Day 1 to 14, per 3-week cycle (monotherapy period).	Sequence 2: Placebo + CRT n=356 Participants Participants received a combination of placebo matched to Debio 1143 along with Chemoradiotherapy(CRT): Radiotherapy +Cisplatin+ placebo matched to Xevinapant (Debio 1143). Participants received 6 cycles of oral solution of placebo matched to Xevinapant once daily from Day 1 to 14, per 3-week cycle in combination with 70 Gray (Gy) of intensity modulated radiation therapy (IMRT) in 35 fractions, 2 Gy/fraction, over 7 weeks, and High-dose cisplatin (100 mg/m2) on Day 2 of a 3-week cycle per 3 cycles(combination therapy period).If high-dose cisplatin 100 mg/m2 was not tolerated after the first dose, participants could be switched to carboplatin (10mg/mL, iv infusion), followed by 3 cycles of monotherapy of placebo matched to Xevinapant from Day 1 to 14, per 3-week cycle (monotherapy period).
Number of Participants With Severity of Grade Greater or Equal to 3 TEAEs	320 Participants	286 Participants

SECONDARY outcome

Timeframe: At Baseline, Cycle 3 Day 1 (C3D1) (combination period), EOT (15 days after last study treatment administration) and baseline upto event free survival (EFS) follow up Month 18 after EOT (max on treatment change)

Population: The SAF set included all participants who received any dose of any of the study intervention (xevinapant/matched placebo, cisplatin/carboplatin, IMRT). Here "overall number of participants analyzed signified" participants who were evaluable for this outcome measure and "number analyzed" signifies participants who were evaluable at specified timepoints.

Change from Baseline in Laboratory Parameters: Basophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets was reported.

Outcome measures

SECONDARY outcome

Timeframe: At Cycle 3 Day 1 (C3D1) (combination period), EOT (15 days after last study treatment administration) and baseline upto event free survival (EFS) follow up Month 18 after EOT (max on treatment change)

Change from Baseline in Laboratory Parameters: Basophils/Leukocytes, Eosinophils/Leukocytes, Lymphocytes/Leukocytes, Monocytes/Leukocytes, Neutrophils/Leukocytes was reported.

Outcome measures

Outcome measures
Measure	Sequence 1: Debio 1143 + CRT n=363 Participants Participants received a combination of Debio 1143 along with Chemoradiotherapy (CRT): Radiotherapy +Cisplatin + Xevinapant (Debio 1143). Participants received 6 cycles of oral solution of Xevinapant at a dose of 200 milligrams per day (mg/day) once daily from Day 1 to 14, per 3-week cycle in combination with 70 Gray (Gy) of intensity modulated radiation therapy (IMRT) in 35 fractions, 2 Gy/fraction, over 7 weeks, and High-dose cisplatin (100 mg/m2) on Day 2 of a 3-week cycle per 3 cycles (combination therapy period). If high-dose cisplatin 100 mg/m2 was not tolerated after the first dose, participants could be switched to carboplatin (10mg/mL, iv infusion), followed by 3 cycles of monotherapy of Xevinapant at a dose of 200 mg/day from Day 1 to 14, per 3-week cycle (monotherapy period).	Sequence 2: Placebo + CRT n=352 Participants Participants received a combination of placebo matched to Debio 1143 along with Chemoradiotherapy(CRT): Radiotherapy +Cisplatin+ placebo matched to Xevinapant (Debio 1143). Participants received 6 cycles of oral solution of placebo matched to Xevinapant once daily from Day 1 to 14, per 3-week cycle in combination with 70 Gray (Gy) of intensity modulated radiation therapy (IMRT) in 35 fractions, 2 Gy/fraction, over 7 weeks, and High-dose cisplatin (100 mg/m2) on Day 2 of a 3-week cycle per 3 cycles(combination therapy period).If high-dose cisplatin 100 mg/m2 was not tolerated after the first dose, participants could be switched to carboplatin (10mg/mL, iv infusion), followed by 3 cycles of monotherapy of placebo matched to Xevinapant from Day 1 to 14, per 3-week cycle (monotherapy period).
Percent Change From Baseline in Laboratory Parameters: Basophils/Leukocytes, Eosinophils/Leukocytes, Lymphocytes/Leukocytes, Monocytes/Leukocytes, Neutrophils/Leukocytes C3D1: Basophils/Leukocytes	-0.21 percent change Standard Deviation 0.551	-0.29 percent change Standard Deviation 0.527
Percent Change From Baseline in Laboratory Parameters: Basophils/Leukocytes, Eosinophils/Leukocytes, Lymphocytes/Leukocytes, Monocytes/Leukocytes, Neutrophils/Leukocytes EOT: Basophils/Leukocytes	-0.14 percent change Standard Deviation 0.502	-0.13 percent change Standard Deviation 0.483
Percent Change From Baseline in Laboratory Parameters: Basophils/Leukocytes, Eosinophils/Leukocytes, Lymphocytes/Leukocytes, Monocytes/Leukocytes, Neutrophils/Leukocytes Max on-treatment change: Basophils/Leukocytes	0.03 percent change Standard Deviation 0.985	0.00 percent change Standard Deviation 1.032
Percent Change From Baseline in Laboratory Parameters: Basophils/Leukocytes, Eosinophils/Leukocytes, Lymphocytes/Leukocytes, Monocytes/Leukocytes, Neutrophils/Leukocytes C3D1: Eosinophils/Leukocytes	-0.04 percent change Standard Deviation 2.874	-0.39 percent change Standard Deviation 2.147
Percent Change From Baseline in Laboratory Parameters: Basophils/Leukocytes, Eosinophils/Leukocytes, Lymphocytes/Leukocytes, Monocytes/Leukocytes, Neutrophils/Leukocytes EOT: Eosinophils/Leukocytes	0.60 percent change Standard Deviation 3.435	0.07 percent change Standard Deviation 1.878
Percent Change From Baseline in Laboratory Parameters: Basophils/Leukocytes, Eosinophils/Leukocytes, Lymphocytes/Leukocytes, Monocytes/Leukocytes, Neutrophils/Leukocytes Max on-treatment change: Eosinophils/Leukocytes	1.32 percent change Standard Deviation 5.005	0.04 percent change Standard Deviation 3.308
Percent Change From Baseline in Laboratory Parameters: Basophils/Leukocytes, Eosinophils/Leukocytes, Lymphocytes/Leukocytes, Monocytes/Leukocytes, Neutrophils/Leukocytes C3D1: Lymphocytes/Leukocytes	-6.89 percent change Standard Deviation 10.604	-5.80 percent change Standard Deviation 10.086
Percent Change From Baseline in Laboratory Parameters: Basophils/Leukocytes, Eosinophils/Leukocytes, Lymphocytes/Leukocytes, Monocytes/Leukocytes, Neutrophils/Leukocytes EOT: Lymphocytes/Leukocytes	-6.85 percent change Standard Deviation 8.855	-6.91 percent change Standard Deviation 7.850
Percent Change From Baseline in Laboratory Parameters: Basophils/Leukocytes, Eosinophils/Leukocytes, Lymphocytes/Leukocytes, Monocytes/Leukocytes, Neutrophils/Leukocytes Max on-treatment change: Lymphocytes/Leukocytes	-11.39 percent change Standard Deviation 15.553	-10.07 percent change Standard Deviation 15.985
Percent Change From Baseline in Laboratory Parameters: Basophils/Leukocytes, Eosinophils/Leukocytes, Lymphocytes/Leukocytes, Monocytes/Leukocytes, Neutrophils/Leukocytes C3D1: Monocytes/Leukocytes	3.65 percent change Standard Deviation 4.502	3.90 percent change Standard Deviation 3.840
Percent Change From Baseline in Laboratory Parameters: Basophils/Leukocytes, Eosinophils/Leukocytes, Lymphocytes/Leukocytes, Monocytes/Leukocytes, Neutrophils/Leukocytes EOT: Monocytes/Leukocytes	0.64 percent change Standard Deviation 2.666	0.89 percent change Standard Deviation 2.454
Percent Change From Baseline in Laboratory Parameters: Basophils/Leukocytes, Eosinophils/Leukocytes, Lymphocytes/Leukocytes, Monocytes/Leukocytes, Neutrophils/Leukocytes Max on-treatment change: Monocytes/Leukocytes	5.87 percent change Standard Deviation 6.060	6.26 percent change Standard Deviation 5.631
Percent Change From Baseline in Laboratory Parameters: Basophils/Leukocytes, Eosinophils/Leukocytes, Lymphocytes/Leukocytes, Monocytes/Leukocytes, Neutrophils/Leukocytes Max on-treatment change: Neutrophils/Leukocytes	6.80 percent change Standard Deviation 24.388	7.45 percent change Standard Deviation 21.764
Percent Change From Baseline in Laboratory Parameters: Basophils/Leukocytes, Eosinophils/Leukocytes, Lymphocytes/Leukocytes, Monocytes/Leukocytes, Neutrophils/Leukocytes C3D1: Neutrophils/Leukocytes	2.67 percent change Standard Deviation 14.064	2.33 percent change Standard Deviation 12.467
Percent Change From Baseline in Laboratory Parameters: Basophils/Leukocytes, Eosinophils/Leukocytes, Lymphocytes/Leukocytes, Monocytes/Leukocytes, Neutrophils/Leukocytes EOT: Neutrophils/Leukocytes	5.75 percent change Standard Deviation 10.651	6.08 percent change Standard Deviation 9.086

SECONDARY outcome

Population: The SAF set included all participants who received any dose of any of the study intervention (xevinapant/matched placebo, cisplatin/carboplatin, IMRT). Here "overall number of participants analyzed" signified participants who were evaluable for this outcome measure and "number analyzed" signifies participants who were evaluable at specified timepoints.

Change from Baseline in Laboratory Parameters: Erythrocytes was reported.

Outcome measures

Outcome measures
Measure	Sequence 1: Debio 1143 + CRT n=363 Participants Participants received a combination of Debio 1143 along with Chemoradiotherapy (CRT): Radiotherapy +Cisplatin + Xevinapant (Debio 1143). Participants received 6 cycles of oral solution of Xevinapant at a dose of 200 milligrams per day (mg/day) once daily from Day 1 to 14, per 3-week cycle in combination with 70 Gray (Gy) of intensity modulated radiation therapy (IMRT) in 35 fractions, 2 Gy/fraction, over 7 weeks, and High-dose cisplatin (100 mg/m2) on Day 2 of a 3-week cycle per 3 cycles (combination therapy period). If high-dose cisplatin 100 mg/m2 was not tolerated after the first dose, participants could be switched to carboplatin (10mg/mL, iv infusion), followed by 3 cycles of monotherapy of Xevinapant at a dose of 200 mg/day from Day 1 to 14, per 3-week cycle (monotherapy period).	Sequence 2: Placebo + CRT n=352 Participants Participants received a combination of placebo matched to Debio 1143 along with Chemoradiotherapy(CRT): Radiotherapy +Cisplatin+ placebo matched to Xevinapant (Debio 1143). Participants received 6 cycles of oral solution of placebo matched to Xevinapant once daily from Day 1 to 14, per 3-week cycle in combination with 70 Gray (Gy) of intensity modulated radiation therapy (IMRT) in 35 fractions, 2 Gy/fraction, over 7 weeks, and High-dose cisplatin (100 mg/m2) on Day 2 of a 3-week cycle per 3 cycles(combination therapy period).If high-dose cisplatin 100 mg/m2 was not tolerated after the first dose, participants could be switched to carboplatin (10mg/mL, iv infusion), followed by 3 cycles of monotherapy of placebo matched to Xevinapant from Day 1 to 14, per 3-week cycle (monotherapy period).
Change From Baseline in Laboratory Parameters: Erythrocytes Max on-treatment change	-1.14 10^12 cells per liter Standard Deviation 0.636	-1.19 10^12 cells per liter Standard Deviation 0.605
Change From Baseline in Laboratory Parameters: Erythrocytes Baseline	4.27 10^12 cells per liter Standard Deviation 0.507	4.37 10^12 cells per liter Standard Deviation 0.477
Change From Baseline in Laboratory Parameters: Erythrocytes C3D1	-0.81 10^12 cells per liter Standard Deviation 0.456	-0.82 10^12 cells per liter Standard Deviation 0.433
Change From Baseline in Laboratory Parameters: Erythrocytes EOT	-0.70 10^12 cells per liter Standard Deviation 0.575	-0.59 10^12 cells per liter Standard Deviation 0.464

SECONDARY outcome

Change from Baseline in Laboratory Parameters: Hemoglobin, Albumin, Protein was reported.

Outcome measures

Outcome measures
Measure	Sequence 1: Debio 1143 + CRT n=364 Participants Participants received a combination of Debio 1143 along with Chemoradiotherapy (CRT): Radiotherapy +Cisplatin + Xevinapant (Debio 1143). Participants received 6 cycles of oral solution of Xevinapant at a dose of 200 milligrams per day (mg/day) once daily from Day 1 to 14, per 3-week cycle in combination with 70 Gray (Gy) of intensity modulated radiation therapy (IMRT) in 35 fractions, 2 Gy/fraction, over 7 weeks, and High-dose cisplatin (100 mg/m2) on Day 2 of a 3-week cycle per 3 cycles (combination therapy period). If high-dose cisplatin 100 mg/m2 was not tolerated after the first dose, participants could be switched to carboplatin (10mg/mL, iv infusion), followed by 3 cycles of monotherapy of Xevinapant at a dose of 200 mg/day from Day 1 to 14, per 3-week cycle (monotherapy period).	Sequence 2: Placebo + CRT n=356 Participants Participants received a combination of placebo matched to Debio 1143 along with Chemoradiotherapy(CRT): Radiotherapy +Cisplatin+ placebo matched to Xevinapant (Debio 1143). Participants received 6 cycles of oral solution of placebo matched to Xevinapant once daily from Day 1 to 14, per 3-week cycle in combination with 70 Gray (Gy) of intensity modulated radiation therapy (IMRT) in 35 fractions, 2 Gy/fraction, over 7 weeks, and High-dose cisplatin (100 mg/m2) on Day 2 of a 3-week cycle per 3 cycles(combination therapy period).If high-dose cisplatin 100 mg/m2 was not tolerated after the first dose, participants could be switched to carboplatin (10mg/mL, iv infusion), followed by 3 cycles of monotherapy of placebo matched to Xevinapant from Day 1 to 14, per 3-week cycle (monotherapy period).
Change From Baseline in Laboratory Parameters: Hemoglobin, Albumin, Protein Hemoglobin: Baseline	132.9 grams per liters (g/L) Standard Deviation 15.08	135.4 grams per liters (g/L) Standard Deviation 14.34
Change From Baseline in Laboratory Parameters: Hemoglobin, Albumin, Protein Hemoglobin: C3D1	-25.7 grams per liters (g/L) Standard Deviation 14.24	-25.2 grams per liters (g/L) Standard Deviation 13.75
Change From Baseline in Laboratory Parameters: Hemoglobin, Albumin, Protein Hemoglobin: EOT	-19.1 grams per liters (g/L) Standard Deviation 17.73	-14.4 grams per liters (g/L) Standard Deviation 14.44
Change From Baseline in Laboratory Parameters: Hemoglobin, Albumin, Protein Hemoglobin: Max on-treatment change	-34.8 grams per liters (g/L) Standard Deviation 19.83	-35.8 grams per liters (g/L) Standard Deviation 18.82
Change From Baseline in Laboratory Parameters: Hemoglobin, Albumin, Protein Albumin: Baseline	43.2 grams per liters (g/L) Standard Deviation 3.95	43.6 grams per liters (g/L) Standard Deviation 3.55
Change From Baseline in Laboratory Parameters: Hemoglobin, Albumin, Protein Albumin: C3D1	-4.0 grams per liters (g/L) Standard Deviation 4.33	-2.6 grams per liters (g/L) Standard Deviation 3.61
Change From Baseline in Laboratory Parameters: Hemoglobin, Albumin, Protein Albumin: EOT	-1.1 grams per liters (g/L) Standard Deviation 4.43	0.4 grams per liters (g/L) Standard Deviation 4.02
Change From Baseline in Laboratory Parameters: Hemoglobin, Albumin, Protein Albumin: Max on-treatment change	-4.8 grams per liters (g/L) Standard Deviation 6.38	-2.6 grams per liters (g/L) Standard Deviation 5.90
Change From Baseline in Laboratory Parameters: Hemoglobin, Albumin, Protein Protein: Baseline	70.1 grams per liters (g/L) Standard Deviation 5.11	70.5 grams per liters (g/L) Standard Deviation 4.78
Change From Baseline in Laboratory Parameters: Hemoglobin, Albumin, Protein Protein: C3D1	-4.5 grams per liters (g/L) Standard Deviation 5.73	-4.3 grams per liters (g/L) Standard Deviation 5.24
Change From Baseline in Laboratory Parameters: Hemoglobin, Albumin, Protein Protein: EOT	-0.3 grams per liters (g/L) Standard Deviation 6.10	-0.7 grams per liters (g/L) Standard Deviation 5.32
Change From Baseline in Laboratory Parameters: Hemoglobin, Albumin, Protein Protein: Max on-treatment change	-4.7 grams per liters (g/L) Standard Deviation 9.12	-5.0 grams per liters (g/L) Standard Deviation 8.03

SECONDARY outcome

Population: The SAF set included all participants who received any dose of any of the study intervention (xevinapant/matched placebo, cisplatin/carboplatin, IMRT). Here "number analyzed" signifies participants who were evaluable at specified timepoints.

Change from Baseline in Laboratory Parameters: Alanine Aminotransferase, Alkaline Phosphatase, Amylase, Aspartate Aminotransferase, Lipase was reported.

Outcome measures

SECONDARY outcome

Change from Baseline in Laboratory Parameters: Bilirubin, Creatinine, Direct Bilirubin, Urate was reported.

Outcome measures

SECONDARY outcome

Change from Baseline in Laboratory Parameters: C Reactive Protein was reported.

Outcome measures

Outcome measures
Measure	Sequence 1: Debio 1143 + CRT n=364 Participants Participants received a combination of Debio 1143 along with Chemoradiotherapy (CRT): Radiotherapy +Cisplatin + Xevinapant (Debio 1143). Participants received 6 cycles of oral solution of Xevinapant at a dose of 200 milligrams per day (mg/day) once daily from Day 1 to 14, per 3-week cycle in combination with 70 Gray (Gy) of intensity modulated radiation therapy (IMRT) in 35 fractions, 2 Gy/fraction, over 7 weeks, and High-dose cisplatin (100 mg/m2) on Day 2 of a 3-week cycle per 3 cycles (combination therapy period). If high-dose cisplatin 100 mg/m2 was not tolerated after the first dose, participants could be switched to carboplatin (10mg/mL, iv infusion), followed by 3 cycles of monotherapy of Xevinapant at a dose of 200 mg/day from Day 1 to 14, per 3-week cycle (monotherapy period).	Sequence 2: Placebo + CRT n=356 Participants Participants received a combination of placebo matched to Debio 1143 along with Chemoradiotherapy(CRT): Radiotherapy +Cisplatin+ placebo matched to Xevinapant (Debio 1143). Participants received 6 cycles of oral solution of placebo matched to Xevinapant once daily from Day 1 to 14, per 3-week cycle in combination with 70 Gray (Gy) of intensity modulated radiation therapy (IMRT) in 35 fractions, 2 Gy/fraction, over 7 weeks, and High-dose cisplatin (100 mg/m2) on Day 2 of a 3-week cycle per 3 cycles(combination therapy period).If high-dose cisplatin 100 mg/m2 was not tolerated after the first dose, participants could be switched to carboplatin (10mg/mL, iv infusion), followed by 3 cycles of monotherapy of placebo matched to Xevinapant from Day 1 to 14, per 3-week cycle (monotherapy period).
Change From Baseline in Laboratory Parameters: C Reactive Protein Baseline	15.80 milligrams per liter (mg/L) Standard Deviation 24.655	13.78 milligrams per liter (mg/L) Standard Deviation 21.780
Change From Baseline in Laboratory Parameters: C Reactive Protein C3D1	25.30 milligrams per liter (mg/L) Standard Deviation 50.259	11.66 milligrams per liter (mg/L) Standard Deviation 36.791
Change From Baseline in Laboratory Parameters: C Reactive Protein EOT	1.26 milligrams per liter (mg/L) Standard Deviation 31.784	1.22 milligrams per liter (mg/L) Standard Deviation 27.720
Change From Baseline in Laboratory Parameters: C Reactive Protein Max on-treatment change	43.91 milligrams per liter (mg/L) Standard Deviation 66.024	27.90 milligrams per liter (mg/L) Standard Deviation 56.262

SECONDARY outcome

Change from Baseline in Laboratory Parameters: Calcium, Magnesium, Potassium, Sodium, Urea was reported.

Outcome measures

SECONDARY outcome

Change from baseline in biochemistry parameter eGFR was reported. The Glomerular Filtration Rate was measured as milliliter per minute per 1.73 square meter (mL/min/1.73m\^2).

Outcome measures

Outcome measures
Measure	Sequence 1: Debio 1143 + CRT n=361 Participants Participants received a combination of Debio 1143 along with Chemoradiotherapy (CRT): Radiotherapy +Cisplatin + Xevinapant (Debio 1143). Participants received 6 cycles of oral solution of Xevinapant at a dose of 200 milligrams per day (mg/day) once daily from Day 1 to 14, per 3-week cycle in combination with 70 Gray (Gy) of intensity modulated radiation therapy (IMRT) in 35 fractions, 2 Gy/fraction, over 7 weeks, and High-dose cisplatin (100 mg/m2) on Day 2 of a 3-week cycle per 3 cycles (combination therapy period). If high-dose cisplatin 100 mg/m2 was not tolerated after the first dose, participants could be switched to carboplatin (10mg/mL, iv infusion), followed by 3 cycles of monotherapy of Xevinapant at a dose of 200 mg/day from Day 1 to 14, per 3-week cycle (monotherapy period).	Sequence 2: Placebo + CRT n=356 Participants Participants received a combination of placebo matched to Debio 1143 along with Chemoradiotherapy(CRT): Radiotherapy +Cisplatin+ placebo matched to Xevinapant (Debio 1143). Participants received 6 cycles of oral solution of placebo matched to Xevinapant once daily from Day 1 to 14, per 3-week cycle in combination with 70 Gray (Gy) of intensity modulated radiation therapy (IMRT) in 35 fractions, 2 Gy/fraction, over 7 weeks, and High-dose cisplatin (100 mg/m2) on Day 2 of a 3-week cycle per 3 cycles(combination therapy period).If high-dose cisplatin 100 mg/m2 was not tolerated after the first dose, participants could be switched to carboplatin (10mg/mL, iv infusion), followed by 3 cycles of monotherapy of placebo matched to Xevinapant from Day 1 to 14, per 3-week cycle (monotherapy period).
Change From Baseline in Estimated Glomerular Filtration Rate Baseline	96.956 mL/min/1.73m*2 Standard Deviation 14.2212	95.244 mL/min/1.73m*2 Standard Deviation 14.1290
Change From Baseline in Estimated Glomerular Filtration Rate C3D1	-8.799 mL/min/1.73m*2 Standard Deviation 19.0295	-9.205 mL/min/1.73m*2 Standard Deviation 18.5178
Change From Baseline in Estimated Glomerular Filtration Rate EOT	-11.385 mL/min/1.73m*2 Standard Deviation 20.6015	-12.594 mL/min/1.73m*2 Standard Deviation 18.0053
Change From Baseline in Estimated Glomerular Filtration Rate Max on-treatment change	-19.439 mL/min/1.73m*2 Standard Deviation 27.3672	-19.528 mL/min/1.73m*2 Standard Deviation 25.7099

SECONDARY outcome

Change from Baseline in coagulation parameter activated PTT/standard and prothrombin Time was reported.

Outcome measures

Outcome measures
Measure	Sequence 1: Debio 1143 + CRT n=349 Participants Participants received a combination of Debio 1143 along with Chemoradiotherapy (CRT): Radiotherapy +Cisplatin + Xevinapant (Debio 1143). Participants received 6 cycles of oral solution of Xevinapant at a dose of 200 milligrams per day (mg/day) once daily from Day 1 to 14, per 3-week cycle in combination with 70 Gray (Gy) of intensity modulated radiation therapy (IMRT) in 35 fractions, 2 Gy/fraction, over 7 weeks, and High-dose cisplatin (100 mg/m2) on Day 2 of a 3-week cycle per 3 cycles (combination therapy period). If high-dose cisplatin 100 mg/m2 was not tolerated after the first dose, participants could be switched to carboplatin (10mg/mL, iv infusion), followed by 3 cycles of monotherapy of Xevinapant at a dose of 200 mg/day from Day 1 to 14, per 3-week cycle (monotherapy period).	Sequence 2: Placebo + CRT n=344 Participants Participants received a combination of placebo matched to Debio 1143 along with Chemoradiotherapy(CRT): Radiotherapy +Cisplatin+ placebo matched to Xevinapant (Debio 1143). Participants received 6 cycles of oral solution of placebo matched to Xevinapant once daily from Day 1 to 14, per 3-week cycle in combination with 70 Gray (Gy) of intensity modulated radiation therapy (IMRT) in 35 fractions, 2 Gy/fraction, over 7 weeks, and High-dose cisplatin (100 mg/m2) on Day 2 of a 3-week cycle per 3 cycles(combination therapy period).If high-dose cisplatin 100 mg/m2 was not tolerated after the first dose, participants could be switched to carboplatin (10mg/mL, iv infusion), followed by 3 cycles of monotherapy of placebo matched to Xevinapant from Day 1 to 14, per 3-week cycle (monotherapy period).
Change From Baseline in Activated Partial Thromboplastin Time (PTT)/ Standard and Prothrombin Time Activated PTT/Standard: C3D1	-0.80 seconds (Sec) Standard Deviation 3.132	-0.91 seconds (Sec) Standard Deviation 2.324
Change From Baseline in Activated Partial Thromboplastin Time (PTT)/ Standard and Prothrombin Time Activated PTT/Standard: EOT	-0.29 seconds (Sec) Standard Deviation 2.812	-0.09 seconds (Sec) Standard Deviation 2.419
Change From Baseline in Activated Partial Thromboplastin Time (PTT)/ Standard and Prothrombin Time Activated PTT/Standard: Max on-treatment change	-1.01 seconds (Sec) Standard Deviation 4.165	-0.87 seconds (Sec) Standard Deviation 3.509
Change From Baseline in Activated Partial Thromboplastin Time (PTT)/ Standard and Prothrombin Time Activated PTT/Standard: Baseline	26.15 seconds (Sec) Standard Deviation 2.349	26.25 seconds (Sec) Standard Deviation 2.540
Change From Baseline in Activated Partial Thromboplastin Time (PTT)/ Standard and Prothrombin Time Prothrombin Time: Baseline	10.50 seconds (Sec) Standard Deviation 0.730	10.73 seconds (Sec) Standard Deviation 1.696
Change From Baseline in Activated Partial Thromboplastin Time (PTT)/ Standard and Prothrombin Time Prothrombin Time: C3D1	0.11 seconds (Sec) Standard Deviation 1.730	-0.17 seconds (Sec) Standard Deviation 1.543
Change From Baseline in Activated Partial Thromboplastin Time (PTT)/ Standard and Prothrombin Time Prothrombin Time: EOT	0.17 seconds (Sec) Standard Deviation 1.757	-0.04 seconds (Sec) Standard Deviation 1.697
Change From Baseline in Activated Partial Thromboplastin Time (PTT)/ Standard and Prothrombin Time Prothrombin Time: Max on-treatment change	0.35 seconds (Sec) Standard Deviation 2.364	-0.01 seconds (Sec) Standard Deviation 1.838

SECONDARY outcome

Change from Baseline in coagulation parameter fibrinogen was reported.

Outcome measures

Outcome measures
Measure	Sequence 1: Debio 1143 + CRT n=348 Participants Participants received a combination of Debio 1143 along with Chemoradiotherapy (CRT): Radiotherapy +Cisplatin + Xevinapant (Debio 1143). Participants received 6 cycles of oral solution of Xevinapant at a dose of 200 milligrams per day (mg/day) once daily from Day 1 to 14, per 3-week cycle in combination with 70 Gray (Gy) of intensity modulated radiation therapy (IMRT) in 35 fractions, 2 Gy/fraction, over 7 weeks, and High-dose cisplatin (100 mg/m2) on Day 2 of a 3-week cycle per 3 cycles (combination therapy period). If high-dose cisplatin 100 mg/m2 was not tolerated after the first dose, participants could be switched to carboplatin (10mg/mL, iv infusion), followed by 3 cycles of monotherapy of Xevinapant at a dose of 200 mg/day from Day 1 to 14, per 3-week cycle (monotherapy period).	Sequence 2: Placebo + CRT n=343 Participants Participants received a combination of placebo matched to Debio 1143 along with Chemoradiotherapy(CRT): Radiotherapy +Cisplatin+ placebo matched to Xevinapant (Debio 1143). Participants received 6 cycles of oral solution of placebo matched to Xevinapant once daily from Day 1 to 14, per 3-week cycle in combination with 70 Gray (Gy) of intensity modulated radiation therapy (IMRT) in 35 fractions, 2 Gy/fraction, over 7 weeks, and High-dose cisplatin (100 mg/m2) on Day 2 of a 3-week cycle per 3 cycles(combination therapy period).If high-dose cisplatin 100 mg/m2 was not tolerated after the first dose, participants could be switched to carboplatin (10mg/mL, iv infusion), followed by 3 cycles of monotherapy of placebo matched to Xevinapant from Day 1 to 14, per 3-week cycle (monotherapy period).
Change From Baseline in Fibrinogen Baseline	486.9 milligrams per deciliter (mg/dl) Standard Deviation 140.35	467.7 milligrams per deciliter (mg/dl) Standard Deviation 119.14
Change From Baseline in Fibrinogen C3D1	121.3 milligrams per deciliter (mg/dl) Standard Deviation 164.05	109.8 milligrams per deciliter (mg/dl) Standard Deviation 157.03
Change From Baseline in Fibrinogen EOT	17.8 milligrams per deciliter (mg/dl) Standard Deviation 150.78	1.0 milligrams per deciliter (mg/dl) Standard Deviation 138.69
Change From Baseline in Fibrinogen Max on-treatment change	112.6 milligrams per deciliter (mg/dl) Standard Deviation 212.46	122.4 milligrams per deciliter (mg/dl) Standard Deviation 207.11

SECONDARY outcome

Change from baseline in coagulation parameters prothrombin international normalized ratio was reported.

Outcome measures

Outcome measures
Measure	Sequence 1: Debio 1143 + CRT n=349 Participants Participants received a combination of Debio 1143 along with Chemoradiotherapy (CRT): Radiotherapy +Cisplatin + Xevinapant (Debio 1143). Participants received 6 cycles of oral solution of Xevinapant at a dose of 200 milligrams per day (mg/day) once daily from Day 1 to 14, per 3-week cycle in combination with 70 Gray (Gy) of intensity modulated radiation therapy (IMRT) in 35 fractions, 2 Gy/fraction, over 7 weeks, and High-dose cisplatin (100 mg/m2) on Day 2 of a 3-week cycle per 3 cycles (combination therapy period). If high-dose cisplatin 100 mg/m2 was not tolerated after the first dose, participants could be switched to carboplatin (10mg/mL, iv infusion), followed by 3 cycles of monotherapy of Xevinapant at a dose of 200 mg/day from Day 1 to 14, per 3-week cycle (monotherapy period).	Sequence 2: Placebo + CRT n=344 Participants Participants received a combination of placebo matched to Debio 1143 along with Chemoradiotherapy(CRT): Radiotherapy +Cisplatin+ placebo matched to Xevinapant (Debio 1143). Participants received 6 cycles of oral solution of placebo matched to Xevinapant once daily from Day 1 to 14, per 3-week cycle in combination with 70 Gray (Gy) of intensity modulated radiation therapy (IMRT) in 35 fractions, 2 Gy/fraction, over 7 weeks, and High-dose cisplatin (100 mg/m2) on Day 2 of a 3-week cycle per 3 cycles(combination therapy period).If high-dose cisplatin 100 mg/m2 was not tolerated after the first dose, participants could be switched to carboplatin (10mg/mL, iv infusion), followed by 3 cycles of monotherapy of placebo matched to Xevinapant from Day 1 to 14, per 3-week cycle (monotherapy period).
Change From Baseline in Prothrombin International Normalized Ratio Baseline	0.96 ratio Standard Deviation 0.090	0.99 ratio Standard Deviation 0.188
Change From Baseline in Prothrombin International Normalized Ratio C3D1	0.01 ratio Standard Deviation 0.195	-0.02 ratio Standard Deviation 0.175
Change From Baseline in Prothrombin International Normalized Ratio EOT	0.02 ratio Standard Deviation 0.197	0.00 ratio Standard Deviation 0.195
Change From Baseline in Prothrombin International Normalized Ratio Max on-treatment change	0.04 ratio Standard Deviation 0.265	0.00 ratio Standard Deviation 0.212

SECONDARY outcome

Change from Baseline in Vital Signs: Systolic Blood Pressure, Diastolic Blood Pressure was reported.

Outcome measures

Outcome measures
Measure	Sequence 1: Debio 1143 + CRT n=364 Participants Participants received a combination of Debio 1143 along with Chemoradiotherapy (CRT): Radiotherapy +Cisplatin + Xevinapant (Debio 1143). Participants received 6 cycles of oral solution of Xevinapant at a dose of 200 milligrams per day (mg/day) once daily from Day 1 to 14, per 3-week cycle in combination with 70 Gray (Gy) of intensity modulated radiation therapy (IMRT) in 35 fractions, 2 Gy/fraction, over 7 weeks, and High-dose cisplatin (100 mg/m2) on Day 2 of a 3-week cycle per 3 cycles (combination therapy period). If high-dose cisplatin 100 mg/m2 was not tolerated after the first dose, participants could be switched to carboplatin (10mg/mL, iv infusion), followed by 3 cycles of monotherapy of Xevinapant at a dose of 200 mg/day from Day 1 to 14, per 3-week cycle (monotherapy period).	Sequence 2: Placebo + CRT n=356 Participants Participants received a combination of placebo matched to Debio 1143 along with Chemoradiotherapy(CRT): Radiotherapy +Cisplatin+ placebo matched to Xevinapant (Debio 1143). Participants received 6 cycles of oral solution of placebo matched to Xevinapant once daily from Day 1 to 14, per 3-week cycle in combination with 70 Gray (Gy) of intensity modulated radiation therapy (IMRT) in 35 fractions, 2 Gy/fraction, over 7 weeks, and High-dose cisplatin (100 mg/m2) on Day 2 of a 3-week cycle per 3 cycles(combination therapy period).If high-dose cisplatin 100 mg/m2 was not tolerated after the first dose, participants could be switched to carboplatin (10mg/mL, iv infusion), followed by 3 cycles of monotherapy of placebo matched to Xevinapant from Day 1 to 14, per 3-week cycle (monotherapy period).
Change From Baseline in Vital Signs: Systolic Blood Pressure, Diastolic Blood Pressure Diastolic BP: Max on-treatment increase	11.1 millimeters of mercury (mmHg) Standard Deviation 7.54	11.2 millimeters of mercury (mmHg) Standard Deviation 8.09
Change From Baseline in Vital Signs: Systolic Blood Pressure, Diastolic Blood Pressure Systolic Blood Pressure: Baseline	128.0 millimeters of mercury (mmHg) Standard Deviation 18.08	128.2 millimeters of mercury (mmHg) Standard Deviation 16.96
Change From Baseline in Vital Signs: Systolic Blood Pressure, Diastolic Blood Pressure Systolic Blood Pressure: C3D1	-10.1 millimeters of mercury (mmHg) Standard Deviation 19.36	-7.9 millimeters of mercury (mmHg) Standard Deviation 17.53
Change From Baseline in Vital Signs: Systolic Blood Pressure, Diastolic Blood Pressure Systolic Blood Pressure: EOT	-5.8 millimeters of mercury (mmHg) Standard Deviation 20.47	-3.4 millimeters of mercury (mmHg) Standard Deviation 20.03
Change From Baseline in Vital Signs: Systolic Blood Pressure, Diastolic Blood Pressure Systolic BP: Max on-treatment increase	15.6 millimeters of mercury (mmHg) Standard Deviation 12.89	16.5 millimeters of mercury (mmHg) Standard Deviation 12.43
Change From Baseline in Vital Signs: Systolic Blood Pressure, Diastolic Blood Pressure Systolic BP: Max on-treatment decrease	-24.7 millimeters of mercury (mmHg) Standard Deviation 15.85	-21.9 millimeters of mercury (mmHg) Standard Deviation 14.48
Change From Baseline in Vital Signs: Systolic Blood Pressure, Diastolic Blood Pressure Diastolic Blood Pressure: Baseline	77.4 millimeters of mercury (mmHg) Standard Deviation 10.60	77.5 millimeters of mercury (mmHg) Standard Deviation 9.75
Change From Baseline in Vital Signs: Systolic Blood Pressure, Diastolic Blood Pressure Diastolic Blood Pressure: C3D1	-5.6 millimeters of mercury (mmHg) Standard Deviation 12.04	-4.0 millimeters of mercury (mmHg) Standard Deviation 10.65
Change From Baseline in Vital Signs: Systolic Blood Pressure, Diastolic Blood Pressure Diastolic Blood Pressure: EOT	-1.8 millimeters of mercury (mmHg) Standard Deviation 12.02	-1.2 millimeters of mercury (mmHg) Standard Deviation 11.55
Change From Baseline in Vital Signs: Systolic Blood Pressure, Diastolic Blood Pressure Diastolic BP: Max on-treatment decrease	-15.2 millimeters of mercury (mmHg) Standard Deviation 9.43	-13.2 millimeters of mercury (mmHg) Standard Deviation 8.42

SECONDARY outcome

Change from Baseline in Vital Signs: Heart Rate was reported.

Outcome measures

Outcome measures
Measure	Sequence 1: Debio 1143 + CRT n=364 Participants Participants received a combination of Debio 1143 along with Chemoradiotherapy (CRT): Radiotherapy +Cisplatin + Xevinapant (Debio 1143). Participants received 6 cycles of oral solution of Xevinapant at a dose of 200 milligrams per day (mg/day) once daily from Day 1 to 14, per 3-week cycle in combination with 70 Gray (Gy) of intensity modulated radiation therapy (IMRT) in 35 fractions, 2 Gy/fraction, over 7 weeks, and High-dose cisplatin (100 mg/m2) on Day 2 of a 3-week cycle per 3 cycles (combination therapy period). If high-dose cisplatin 100 mg/m2 was not tolerated after the first dose, participants could be switched to carboplatin (10mg/mL, iv infusion), followed by 3 cycles of monotherapy of Xevinapant at a dose of 200 mg/day from Day 1 to 14, per 3-week cycle (monotherapy period).	Sequence 2: Placebo + CRT n=356 Participants Participants received a combination of placebo matched to Debio 1143 along with Chemoradiotherapy(CRT): Radiotherapy +Cisplatin+ placebo matched to Xevinapant (Debio 1143). Participants received 6 cycles of oral solution of placebo matched to Xevinapant once daily from Day 1 to 14, per 3-week cycle in combination with 70 Gray (Gy) of intensity modulated radiation therapy (IMRT) in 35 fractions, 2 Gy/fraction, over 7 weeks, and High-dose cisplatin (100 mg/m2) on Day 2 of a 3-week cycle per 3 cycles(combination therapy period).If high-dose cisplatin 100 mg/m2 was not tolerated after the first dose, participants could be switched to carboplatin (10mg/mL, iv infusion), followed by 3 cycles of monotherapy of placebo matched to Xevinapant from Day 1 to 14, per 3-week cycle (monotherapy period).
Change From Baseline in Vital Signs: Heart Rate Heart Rate: Baseline	77.6 beats/minute Standard Deviation 12.35	76.1 beats/minute Standard Deviation 12.60
Change From Baseline in Vital Signs: Heart Rate Heart Rate: C3D1	5.2 beats/minute Standard Deviation 13.71	3.4 beats/minute Standard Deviation 13.92
Change From Baseline in Vital Signs: Heart Rate Heart Rate: EOT	2.8 beats/minute Standard Deviation 14.33	2.2 beats/minute Standard Deviation 13.51
Change From Baseline in Vital Signs: Heart Rate Heart Rate: Max on-treatment increase	17.8 beats/minute Standard Deviation 12.30	16.7 beats/minute Standard Deviation 10.97
Change From Baseline in Vital Signs: Heart Rate Heart Rate: Max on-treatment decrease	-11.7 beats/minute Standard Deviation 9.00	-12.2 beats/minute Standard Deviation 9.13

SECONDARY outcome

Change from Baseline in Vital Signs: Respiratory Rate was reported.

Outcome measures

Outcome measures
Measure	Sequence 1: Debio 1143 + CRT n=359 Participants Participants received a combination of Debio 1143 along with Chemoradiotherapy (CRT): Radiotherapy +Cisplatin + Xevinapant (Debio 1143). Participants received 6 cycles of oral solution of Xevinapant at a dose of 200 milligrams per day (mg/day) once daily from Day 1 to 14, per 3-week cycle in combination with 70 Gray (Gy) of intensity modulated radiation therapy (IMRT) in 35 fractions, 2 Gy/fraction, over 7 weeks, and High-dose cisplatin (100 mg/m2) on Day 2 of a 3-week cycle per 3 cycles (combination therapy period). If high-dose cisplatin 100 mg/m2 was not tolerated after the first dose, participants could be switched to carboplatin (10mg/mL, iv infusion), followed by 3 cycles of monotherapy of Xevinapant at a dose of 200 mg/day from Day 1 to 14, per 3-week cycle (monotherapy period).	Sequence 2: Placebo + CRT n=355 Participants Participants received a combination of placebo matched to Debio 1143 along with Chemoradiotherapy(CRT): Radiotherapy +Cisplatin+ placebo matched to Xevinapant (Debio 1143). Participants received 6 cycles of oral solution of placebo matched to Xevinapant once daily from Day 1 to 14, per 3-week cycle in combination with 70 Gray (Gy) of intensity modulated radiation therapy (IMRT) in 35 fractions, 2 Gy/fraction, over 7 weeks, and High-dose cisplatin (100 mg/m2) on Day 2 of a 3-week cycle per 3 cycles(combination therapy period).If high-dose cisplatin 100 mg/m2 was not tolerated after the first dose, participants could be switched to carboplatin (10mg/mL, iv infusion), followed by 3 cycles of monotherapy of placebo matched to Xevinapant from Day 1 to 14, per 3-week cycle (monotherapy period).
Change From Baseline in Vital Signs: Respiratory Rate Respiratory Rate: C3D1	-0.1 breaths/minute Standard Deviation 2.65	0.0 breaths/minute Standard Deviation 2.76
Change From Baseline in Vital Signs: Respiratory Rate Respiratory Rate: EOT	-0.1 breaths/minute Standard Deviation 2.83	-0.1 breaths/minute Standard Deviation 3.01
Change From Baseline in Vital Signs: Respiratory Rate Respiratory Rate: Max on-treatment increase	3.2 breaths/minute Standard Deviation 2.66	2.7 breaths/minute Standard Deviation 2.13
Change From Baseline in Vital Signs: Respiratory Rate Respiratory Rate: Max on-treatment decrease	-3.1 breaths/minute Standard Deviation 2.52	-2.7 breaths/minute Standard Deviation 2.88
Change From Baseline in Vital Signs: Respiratory Rate Respiratory Rate: Baseline	16.8 breaths/minute Standard Deviation 2.38	16.7 breaths/minute Standard Deviation 2.98

SECONDARY outcome

Change from Baseline in Vital Signs: Body Temperature was reported.

Outcome measures

Outcome measures
Measure	Sequence 1: Debio 1143 + CRT n=364 Participants Participants received a combination of Debio 1143 along with Chemoradiotherapy (CRT): Radiotherapy +Cisplatin + Xevinapant (Debio 1143). Participants received 6 cycles of oral solution of Xevinapant at a dose of 200 milligrams per day (mg/day) once daily from Day 1 to 14, per 3-week cycle in combination with 70 Gray (Gy) of intensity modulated radiation therapy (IMRT) in 35 fractions, 2 Gy/fraction, over 7 weeks, and High-dose cisplatin (100 mg/m2) on Day 2 of a 3-week cycle per 3 cycles (combination therapy period). If high-dose cisplatin 100 mg/m2 was not tolerated after the first dose, participants could be switched to carboplatin (10mg/mL, iv infusion), followed by 3 cycles of monotherapy of Xevinapant at a dose of 200 mg/day from Day 1 to 14, per 3-week cycle (monotherapy period).	Sequence 2: Placebo + CRT n=355 Participants Participants received a combination of placebo matched to Debio 1143 along with Chemoradiotherapy(CRT): Radiotherapy +Cisplatin+ placebo matched to Xevinapant (Debio 1143). Participants received 6 cycles of oral solution of placebo matched to Xevinapant once daily from Day 1 to 14, per 3-week cycle in combination with 70 Gray (Gy) of intensity modulated radiation therapy (IMRT) in 35 fractions, 2 Gy/fraction, over 7 weeks, and High-dose cisplatin (100 mg/m2) on Day 2 of a 3-week cycle per 3 cycles(combination therapy period).If high-dose cisplatin 100 mg/m2 was not tolerated after the first dose, participants could be switched to carboplatin (10mg/mL, iv infusion), followed by 3 cycles of monotherapy of placebo matched to Xevinapant from Day 1 to 14, per 3-week cycle (monotherapy period).
Change From Baseline in Vital Signs: Body Temperature Baseline	36.44 degree Celsius Standard Deviation 0.443	36.41 degree Celsius Standard Deviation 0.432
Change From Baseline in Vital Signs: Body Temperature C3D1	0.10 degree Celsius Standard Deviation 36.49	0.07 degree Celsius Standard Deviation 0.476
Change From Baseline in Vital Signs: Body Temperature EOT	0.00 degree Celsius Standard Deviation 0.463	0.00 degree Celsius Standard Deviation 0.453
Change From Baseline in Vital Signs: Body Temperature Max on-treatment increase	0.57 degree Celsius Standard Deviation 0.445	0.51 degree Celsius Standard Deviation 0.413

SECONDARY outcome

Timeframe: At Baseline, C3D1 (combination period), EOT (15 days after last study treatment administration) and baseline upto event free survival (EFS) follow up Month 18 after EOT (max on treatment increase & decrease)

Change from Baseline in Vital Signs: Body Weight was reported.

Outcome measures

Outcome measures
Measure	Sequence 1: Debio 1143 + CRT n=364 Participants Participants received a combination of Debio 1143 along with Chemoradiotherapy (CRT): Radiotherapy +Cisplatin + Xevinapant (Debio 1143). Participants received 6 cycles of oral solution of Xevinapant at a dose of 200 milligrams per day (mg/day) once daily from Day 1 to 14, per 3-week cycle in combination with 70 Gray (Gy) of intensity modulated radiation therapy (IMRT) in 35 fractions, 2 Gy/fraction, over 7 weeks, and High-dose cisplatin (100 mg/m2) on Day 2 of a 3-week cycle per 3 cycles (combination therapy period). If high-dose cisplatin 100 mg/m2 was not tolerated after the first dose, participants could be switched to carboplatin (10mg/mL, iv infusion), followed by 3 cycles of monotherapy of Xevinapant at a dose of 200 mg/day from Day 1 to 14, per 3-week cycle (monotherapy period).	Sequence 2: Placebo + CRT n=356 Participants Participants received a combination of placebo matched to Debio 1143 along with Chemoradiotherapy(CRT): Radiotherapy +Cisplatin+ placebo matched to Xevinapant (Debio 1143). Participants received 6 cycles of oral solution of placebo matched to Xevinapant once daily from Day 1 to 14, per 3-week cycle in combination with 70 Gray (Gy) of intensity modulated radiation therapy (IMRT) in 35 fractions, 2 Gy/fraction, over 7 weeks, and High-dose cisplatin (100 mg/m2) on Day 2 of a 3-week cycle per 3 cycles(combination therapy period).If high-dose cisplatin 100 mg/m2 was not tolerated after the first dose, participants could be switched to carboplatin (10mg/mL, iv infusion), followed by 3 cycles of monotherapy of placebo matched to Xevinapant from Day 1 to 14, per 3-week cycle (monotherapy period).
Change From Baseline in Vital Signs: Body Weight Baseline	69.552 kilograms (kg) Standard Deviation 16.8493	70.261 kilograms (kg) Standard Deviation 15.2793
Change From Baseline in Vital Signs: Body Weight C3D1	-4.762 kilograms (kg) Standard Deviation 3.9129	-4.331 kilograms (kg) Standard Deviation 3.6001
Change From Baseline in Vital Signs: Body Weight EOT	-6.282 kilograms (kg) Standard Deviation 6.1160	-4.819 kilograms (kg) Standard Deviation 5.9718
Change From Baseline in Vital Signs: Body Weight Max on-treatment increase	2.497 kilograms (kg) Standard Deviation 2.1157	2.549 kilograms (kg) Standard Deviation 2.7503
Change From Baseline in Vital Signs: Body Weight Max on-treatment decrease	-8.182 kilograms (kg) Standard Deviation 5.1605	-7.379 kilograms (kg) Standard Deviation 4.8001

SECONDARY outcome

Timeframe: At Baseline, and upto event free survival (EFS) follow up Month 18 after EOT (max on treatment increase)

The 12-lead ECGs were recorded after the participants have rested for at least 5 minutes in supine position. The parameters included Respiratory Rate (RR), Pulse Rate (PR), QRS, QT and QTcF calculated by the Bazett formula.

Outcome measures

Outcome measures
Measure	Sequence 1: Debio 1143 + CRT n=364 Participants Participants received a combination of Debio 1143 along with Chemoradiotherapy (CRT): Radiotherapy +Cisplatin + Xevinapant (Debio 1143). Participants received 6 cycles of oral solution of Xevinapant at a dose of 200 milligrams per day (mg/day) once daily from Day 1 to 14, per 3-week cycle in combination with 70 Gray (Gy) of intensity modulated radiation therapy (IMRT) in 35 fractions, 2 Gy/fraction, over 7 weeks, and High-dose cisplatin (100 mg/m2) on Day 2 of a 3-week cycle per 3 cycles (combination therapy period). If high-dose cisplatin 100 mg/m2 was not tolerated after the first dose, participants could be switched to carboplatin (10mg/mL, iv infusion), followed by 3 cycles of monotherapy of Xevinapant at a dose of 200 mg/day from Day 1 to 14, per 3-week cycle (monotherapy period).	Sequence 2: Placebo + CRT n=356 Participants Participants received a combination of placebo matched to Debio 1143 along with Chemoradiotherapy(CRT): Radiotherapy +Cisplatin+ placebo matched to Xevinapant (Debio 1143). Participants received 6 cycles of oral solution of placebo matched to Xevinapant once daily from Day 1 to 14, per 3-week cycle in combination with 70 Gray (Gy) of intensity modulated radiation therapy (IMRT) in 35 fractions, 2 Gy/fraction, over 7 weeks, and High-dose cisplatin (100 mg/m2) on Day 2 of a 3-week cycle per 3 cycles(combination therapy period).If high-dose cisplatin 100 mg/m2 was not tolerated after the first dose, participants could be switched to carboplatin (10mg/mL, iv infusion), followed by 3 cycles of monotherapy of placebo matched to Xevinapant from Day 1 to 14, per 3-week cycle (monotherapy period).
Change From Baseline in ECG Parameters PR Interval: Baseline	154.6 millisecond Standard Deviation 28.05	159.2 millisecond Standard Deviation 29.85
Change From Baseline in ECG Parameters PR Interval: Max on-treatment increase	15.2 millisecond Standard Deviation 16.48	15.8 millisecond Standard Deviation 19.90
Change From Baseline in ECG Parameters QRS Duration: Baseline	90.4 millisecond Standard Deviation 14.78	91.9 millisecond Standard Deviation 14.48
Change From Baseline in ECG Parameters QRS Duration: Max on-treatment increase	9.8 millisecond Standard Deviation 9.87	9.8 millisecond Standard Deviation 21.97
Change From Baseline in ECG Parameters QT Interval: Baseline	381.9 millisecond Standard Deviation 30.29	385.7 millisecond Standard Deviation 33.47
Change From Baseline in ECG Parameters QT Interval: Max on-treatment increase	33.3 millisecond Standard Deviation 26.91	26.9 millisecond Standard Deviation 21.78
Change From Baseline in ECG Parameters RR Interval: Baseline	824.5 millisecond Standard Deviation 163.43	858.0 millisecond Standard Deviation 153.30
Change From Baseline in ECG Parameters RR Interval: Max on-treatment increase	139.5 millisecond Standard Deviation 125.19	117.2 millisecond Standard Deviation 87.11
Change From Baseline in ECG Parameters QTcF Interval: Baseline	406.3 millisecond Standard Deviation 22.78	406.6 millisecond Standard Deviation 25.06
Change From Baseline in ECG Parameters QTcF Interval: Max on-treatment increase	24.9 millisecond Standard Deviation 21.27	19.7 millisecond Standard Deviation 19.17

SECONDARY outcome

Timeframe: Up to end of study (up to 188weeks and 5 days)

Treatment duration is calculated by study treatment component as (last dose date minus first dose date plus x)/7, where x=8 for xevinapant/matched placebo, x=21 for cisplatin/carboplatin, x=3 for IMRT.

Outcome measures

Outcome measures
Measure	Sequence 1: Debio 1143 + CRT n=364 Participants Participants received a combination of Debio 1143 along with Chemoradiotherapy (CRT): Radiotherapy +Cisplatin + Xevinapant (Debio 1143). Participants received 6 cycles of oral solution of Xevinapant at a dose of 200 milligrams per day (mg/day) once daily from Day 1 to 14, per 3-week cycle in combination with 70 Gray (Gy) of intensity modulated radiation therapy (IMRT) in 35 fractions, 2 Gy/fraction, over 7 weeks, and High-dose cisplatin (100 mg/m2) on Day 2 of a 3-week cycle per 3 cycles (combination therapy period). If high-dose cisplatin 100 mg/m2 was not tolerated after the first dose, participants could be switched to carboplatin (10mg/mL, iv infusion), followed by 3 cycles of monotherapy of Xevinapant at a dose of 200 mg/day from Day 1 to 14, per 3-week cycle (monotherapy period).	Sequence 2: Placebo + CRT n=356 Participants Participants received a combination of placebo matched to Debio 1143 along with Chemoradiotherapy(CRT): Radiotherapy +Cisplatin+ placebo matched to Xevinapant (Debio 1143). Participants received 6 cycles of oral solution of placebo matched to Xevinapant once daily from Day 1 to 14, per 3-week cycle in combination with 70 Gray (Gy) of intensity modulated radiation therapy (IMRT) in 35 fractions, 2 Gy/fraction, over 7 weeks, and High-dose cisplatin (100 mg/m2) on Day 2 of a 3-week cycle per 3 cycles(combination therapy period).If high-dose cisplatin 100 mg/m2 was not tolerated after the first dose, participants could be switched to carboplatin (10mg/mL, iv infusion), followed by 3 cycles of monotherapy of placebo matched to Xevinapant from Day 1 to 14, per 3-week cycle (monotherapy period).
Treatment Duration Carboplatin	3.00 weeks Interval 3.0 to 6.0	3.00 weeks Interval 3.0 to 6.0
Treatment Duration IMRT	7.43 weeks Interval 7.21 to 7.86	7.43 weeks Interval 7.29 to 7.71
Treatment Duration Xevinapant/matched placebo	18.00 weeks Interval 10.71 to 18.14	18.00 weeks Interval 18.0 to 18.29
Treatment Duration Cisplatin	8.86 weeks Interval 6.0 to 9.0	9.00 weeks Interval 6.0 to 9.0

SECONDARY outcome

Timeframe: Cycle 1, 2, 3, 4, 5 and 6 (each cycle is of 3 weeks)

Population: The SAF set included all participants who received any dose of any of the study intervention (xevinapant/matched placebo, cisplatin/carboplatin, IMRT).

Number of participants who completed cycle 1, 2, 3, 4, 5 or 6 of xevinapant/matched placebo were reported.

Outcome measures

Outcome measures
Measure	Sequence 1: Debio 1143 + CRT n=364 Participants Participants received a combination of Debio 1143 along with Chemoradiotherapy (CRT): Radiotherapy +Cisplatin + Xevinapant (Debio 1143). Participants received 6 cycles of oral solution of Xevinapant at a dose of 200 milligrams per day (mg/day) once daily from Day 1 to 14, per 3-week cycle in combination with 70 Gray (Gy) of intensity modulated radiation therapy (IMRT) in 35 fractions, 2 Gy/fraction, over 7 weeks, and High-dose cisplatin (100 mg/m2) on Day 2 of a 3-week cycle per 3 cycles (combination therapy period). If high-dose cisplatin 100 mg/m2 was not tolerated after the first dose, participants could be switched to carboplatin (10mg/mL, iv infusion), followed by 3 cycles of monotherapy of Xevinapant at a dose of 200 mg/day from Day 1 to 14, per 3-week cycle (monotherapy period).	Sequence 2: Placebo + CRT n=356 Participants Participants received a combination of placebo matched to Debio 1143 along with Chemoradiotherapy(CRT): Radiotherapy +Cisplatin+ placebo matched to Xevinapant (Debio 1143). Participants received 6 cycles of oral solution of placebo matched to Xevinapant once daily from Day 1 to 14, per 3-week cycle in combination with 70 Gray (Gy) of intensity modulated radiation therapy (IMRT) in 35 fractions, 2 Gy/fraction, over 7 weeks, and High-dose cisplatin (100 mg/m2) on Day 2 of a 3-week cycle per 3 cycles(combination therapy period).If high-dose cisplatin 100 mg/m2 was not tolerated after the first dose, participants could be switched to carboplatin (10mg/mL, iv infusion), followed by 3 cycles of monotherapy of placebo matched to Xevinapant from Day 1 to 14, per 3-week cycle (monotherapy period).
Number of Participants Who Completed Cycle 1, 2, 3, 4, 5 and 6 Cycle 1	363 count of participants	355 count of participants
Number of Participants Who Completed Cycle 1, 2, 3, 4, 5 and 6 Cycle 2	325 count of participants	335 count of participants
Number of Participants Who Completed Cycle 1, 2, 3, 4, 5 and 6 Cycle 3	290 count of participants	314 count of participants
Number of Participants Who Completed Cycle 1, 2, 3, 4, 5 and 6 Cycle 4	266 count of participants	210 count of participants
Number of Participants Who Completed Cycle 1, 2, 3, 4, 5 and 6 Cycle 5	263 count of participants	307 count of participants
Number of Participants Who Completed Cycle 1, 2, 3, 4, 5 and 6 Cycle 6	246 count of participants	297 count of participants

SECONDARY outcome

Timeframe: Up to end of treatment (Day 134)

Total cumulative dose of Xevinapant/ Matched Placebo was reported in form of mean and standard deviation.

Outcome measures

Outcome measures
Measure	Sequence 1: Debio 1143 + CRT n=364 Participants Participants received a combination of Debio 1143 along with Chemoradiotherapy (CRT): Radiotherapy +Cisplatin + Xevinapant (Debio 1143). Participants received 6 cycles of oral solution of Xevinapant at a dose of 200 milligrams per day (mg/day) once daily from Day 1 to 14, per 3-week cycle in combination with 70 Gray (Gy) of intensity modulated radiation therapy (IMRT) in 35 fractions, 2 Gy/fraction, over 7 weeks, and High-dose cisplatin (100 mg/m2) on Day 2 of a 3-week cycle per 3 cycles (combination therapy period). If high-dose cisplatin 100 mg/m2 was not tolerated after the first dose, participants could be switched to carboplatin (10mg/mL, iv infusion), followed by 3 cycles of monotherapy of Xevinapant at a dose of 200 mg/day from Day 1 to 14, per 3-week cycle (monotherapy period).	Sequence 2: Placebo + CRT n=355 Participants Participants received a combination of placebo matched to Debio 1143 along with Chemoradiotherapy(CRT): Radiotherapy +Cisplatin+ placebo matched to Xevinapant (Debio 1143). Participants received 6 cycles of oral solution of placebo matched to Xevinapant once daily from Day 1 to 14, per 3-week cycle in combination with 70 Gray (Gy) of intensity modulated radiation therapy (IMRT) in 35 fractions, 2 Gy/fraction, over 7 weeks, and High-dose cisplatin (100 mg/m2) on Day 2 of a 3-week cycle per 3 cycles(combination therapy period).If high-dose cisplatin 100 mg/m2 was not tolerated after the first dose, participants could be switched to carboplatin (10mg/mL, iv infusion), followed by 3 cycles of monotherapy of placebo matched to Xevinapant from Day 1 to 14, per 3-week cycle (monotherapy period).
Total Cumulative Dose of Xevinapant/ Matched Placebo	12383.6 milligrams (mg) Standard Deviation 5375.66	14417.0 milligrams (mg) Standard Deviation 4288.55

SECONDARY outcome

Timeframe: Up to end of treatment (Day 134)

Population: The SAF set included all participants who received any dose of any of the study intervention (xevinapant/matched placebo, cisplatin/carboplatin, IMRT). Here" overall number of participants analyzed signified" participants who were evaluable for this outcome measure.

Total cumulative dose of cisplatin was reported.

Outcome measures

Outcome measures
Measure	Sequence 1: Debio 1143 + CRT n=360 Participants Participants received a combination of Debio 1143 along with Chemoradiotherapy (CRT): Radiotherapy +Cisplatin + Xevinapant (Debio 1143). Participants received 6 cycles of oral solution of Xevinapant at a dose of 200 milligrams per day (mg/day) once daily from Day 1 to 14, per 3-week cycle in combination with 70 Gray (Gy) of intensity modulated radiation therapy (IMRT) in 35 fractions, 2 Gy/fraction, over 7 weeks, and High-dose cisplatin (100 mg/m2) on Day 2 of a 3-week cycle per 3 cycles (combination therapy period). If high-dose cisplatin 100 mg/m2 was not tolerated after the first dose, participants could be switched to carboplatin (10mg/mL, iv infusion), followed by 3 cycles of monotherapy of Xevinapant at a dose of 200 mg/day from Day 1 to 14, per 3-week cycle (monotherapy period).	Sequence 2: Placebo + CRT n=351 Participants Participants received a combination of placebo matched to Debio 1143 along with Chemoradiotherapy(CRT): Radiotherapy +Cisplatin+ placebo matched to Xevinapant (Debio 1143). Participants received 6 cycles of oral solution of placebo matched to Xevinapant once daily from Day 1 to 14, per 3-week cycle in combination with 70 Gray (Gy) of intensity modulated radiation therapy (IMRT) in 35 fractions, 2 Gy/fraction, over 7 weeks, and High-dose cisplatin (100 mg/m2) on Day 2 of a 3-week cycle per 3 cycles(combination therapy period).If high-dose cisplatin 100 mg/m2 was not tolerated after the first dose, participants could be switched to carboplatin (10mg/mL, iv infusion), followed by 3 cycles of monotherapy of placebo matched to Xevinapant from Day 1 to 14, per 3-week cycle (monotherapy period).
Total Cumulative Dose of Cisplatin	223.3 milligrams per square meter (mg/m^2) Standard Deviation 76.26	236.3 milligrams per square meter (mg/m^2) Standard Deviation 73.14

SECONDARY outcome

Timeframe: Up to end of treatment (Day 134)

Total cumulative dose of carboplatin was reported as mean and standard deviation.

Outcome measures

Outcome measures
Measure	Sequence 1: Debio 1143 + CRT n=54 Participants Participants received a combination of Debio 1143 along with Chemoradiotherapy (CRT): Radiotherapy +Cisplatin + Xevinapant (Debio 1143). Participants received 6 cycles of oral solution of Xevinapant at a dose of 200 milligrams per day (mg/day) once daily from Day 1 to 14, per 3-week cycle in combination with 70 Gray (Gy) of intensity modulated radiation therapy (IMRT) in 35 fractions, 2 Gy/fraction, over 7 weeks, and High-dose cisplatin (100 mg/m2) on Day 2 of a 3-week cycle per 3 cycles (combination therapy period). If high-dose cisplatin 100 mg/m2 was not tolerated after the first dose, participants could be switched to carboplatin (10mg/mL, iv infusion), followed by 3 cycles of monotherapy of Xevinapant at a dose of 200 mg/day from Day 1 to 14, per 3-week cycle (monotherapy period).	Sequence 2: Placebo + CRT n=60 Participants Participants received a combination of placebo matched to Debio 1143 along with Chemoradiotherapy(CRT): Radiotherapy +Cisplatin+ placebo matched to Xevinapant (Debio 1143). Participants received 6 cycles of oral solution of placebo matched to Xevinapant once daily from Day 1 to 14, per 3-week cycle in combination with 70 Gray (Gy) of intensity modulated radiation therapy (IMRT) in 35 fractions, 2 Gy/fraction, over 7 weeks, and High-dose cisplatin (100 mg/m2) on Day 2 of a 3-week cycle per 3 cycles(combination therapy period).If high-dose cisplatin 100 mg/m2 was not tolerated after the first dose, participants could be switched to carboplatin (10mg/mL, iv infusion), followed by 3 cycles of monotherapy of placebo matched to Xevinapant from Day 1 to 14, per 3-week cycle (monotherapy period).
Total Cumulative Dose of Carboplatin	6.9 mg*min/mL Standard Deviation 2.37	6.6 mg*min/mL Standard Deviation 2.26

SECONDARY outcome

Timeframe: Up to end of treatment (Day 134)

Population: The SAF set included all participants who received any dose of any of the study intervention (xevinapant/matched placebo, cisplatin/carboplatin, IMRT). Here" overall number of participants analyzed signified" participants who were evaluable for this outcome measure.

Total cumulative dose of IMRT were reported in form of mean and standard deviation.

Outcome measures

Outcome measures
Measure	Sequence 1: Debio 1143 + CRT n=364 Participants Participants received a combination of Debio 1143 along with Chemoradiotherapy (CRT): Radiotherapy +Cisplatin + Xevinapant (Debio 1143). Participants received 6 cycles of oral solution of Xevinapant at a dose of 200 milligrams per day (mg/day) once daily from Day 1 to 14, per 3-week cycle in combination with 70 Gray (Gy) of intensity modulated radiation therapy (IMRT) in 35 fractions, 2 Gy/fraction, over 7 weeks, and High-dose cisplatin (100 mg/m2) on Day 2 of a 3-week cycle per 3 cycles (combination therapy period). If high-dose cisplatin 100 mg/m2 was not tolerated after the first dose, participants could be switched to carboplatin (10mg/mL, iv infusion), followed by 3 cycles of monotherapy of Xevinapant at a dose of 200 mg/day from Day 1 to 14, per 3-week cycle (monotherapy period).	Sequence 2: Placebo + CRT n=355 Participants Participants received a combination of placebo matched to Debio 1143 along with Chemoradiotherapy(CRT): Radiotherapy +Cisplatin+ placebo matched to Xevinapant (Debio 1143). Participants received 6 cycles of oral solution of placebo matched to Xevinapant once daily from Day 1 to 14, per 3-week cycle in combination with 70 Gray (Gy) of intensity modulated radiation therapy (IMRT) in 35 fractions, 2 Gy/fraction, over 7 weeks, and High-dose cisplatin (100 mg/m2) on Day 2 of a 3-week cycle per 3 cycles(combination therapy period).If high-dose cisplatin 100 mg/m2 was not tolerated after the first dose, participants could be switched to carboplatin (10mg/mL, iv infusion), followed by 3 cycles of monotherapy of placebo matched to Xevinapant from Day 1 to 14, per 3-week cycle (monotherapy period).
Total Cumulative Dose of Intensity-Modulated Radiation Therapy (IMRT)	66.4 Gray (Gy) Standard Deviation 12.32	67.9 Gray (Gy) Standard Deviation 9.74

SECONDARY outcome

Timeframe: Cycle 1, 2, 3, 4 5, 6 (each cycle is of 3 weeks) or End of Treatment (Day 134)

Population: The SAF set included all participants who received any dose of any of the study intervention (xevinapant/matched placebo, cisplatin/carboplatin, IMRT).Here "overall number of participants analyzed signified" participants who were evaluable for this outcome measure.

Overall dose intensity of Xevinapant/ matched placebo is calculated as the mean of the dose intensities of the individual cycles.

Outcome measures

Outcome measures
Measure	Sequence 1: Debio 1143 + CRT n=364 Participants Participants received a combination of Debio 1143 along with Chemoradiotherapy (CRT): Radiotherapy +Cisplatin + Xevinapant (Debio 1143). Participants received 6 cycles of oral solution of Xevinapant at a dose of 200 milligrams per day (mg/day) once daily from Day 1 to 14, per 3-week cycle in combination with 70 Gray (Gy) of intensity modulated radiation therapy (IMRT) in 35 fractions, 2 Gy/fraction, over 7 weeks, and High-dose cisplatin (100 mg/m2) on Day 2 of a 3-week cycle per 3 cycles (combination therapy period). If high-dose cisplatin 100 mg/m2 was not tolerated after the first dose, participants could be switched to carboplatin (10mg/mL, iv infusion), followed by 3 cycles of monotherapy of Xevinapant at a dose of 200 mg/day from Day 1 to 14, per 3-week cycle (monotherapy period).	Sequence 2: Placebo + CRT n=355 Participants Participants received a combination of placebo matched to Debio 1143 along with Chemoradiotherapy(CRT): Radiotherapy +Cisplatin+ placebo matched to Xevinapant (Debio 1143). Participants received 6 cycles of oral solution of placebo matched to Xevinapant once daily from Day 1 to 14, per 3-week cycle in combination with 70 Gray (Gy) of intensity modulated radiation therapy (IMRT) in 35 fractions, 2 Gy/fraction, over 7 weeks, and High-dose cisplatin (100 mg/m2) on Day 2 of a 3-week cycle per 3 cycles(combination therapy period).If high-dose cisplatin 100 mg/m2 was not tolerated after the first dose, participants could be switched to carboplatin (10mg/mL, iv infusion), followed by 3 cycles of monotherapy of placebo matched to Xevinapant from Day 1 to 14, per 3-week cycle (monotherapy period).
Overall Dose Intensity of Xevinapant/Matched Placebo	122.72 milligrams per day (mg/day) Standard Deviation 18.274	126.56 milligrams per day (mg/day) Standard Deviation 16.495

SECONDARY outcome

Timeframe: Cycle 1, 2, 3, 4 5, 6 (each cycle is of 3 weeks) or End of Treatment (Day 134)

Overall dose intensity of Cisplatin is calculated as the mean of the dose intensities of the individual cycles. This was reported with the unit of measure milligrams per meter square per week (mg/m2/week).

Outcome measures

Outcome measures
Measure	Sequence 1: Debio 1143 + CRT n=360 Participants Participants received a combination of Debio 1143 along with Chemoradiotherapy (CRT): Radiotherapy +Cisplatin + Xevinapant (Debio 1143). Participants received 6 cycles of oral solution of Xevinapant at a dose of 200 milligrams per day (mg/day) once daily from Day 1 to 14, per 3-week cycle in combination with 70 Gray (Gy) of intensity modulated radiation therapy (IMRT) in 35 fractions, 2 Gy/fraction, over 7 weeks, and High-dose cisplatin (100 mg/m2) on Day 2 of a 3-week cycle per 3 cycles (combination therapy period). If high-dose cisplatin 100 mg/m2 was not tolerated after the first dose, participants could be switched to carboplatin (10mg/mL, iv infusion), followed by 3 cycles of monotherapy of Xevinapant at a dose of 200 mg/day from Day 1 to 14, per 3-week cycle (monotherapy period).	Sequence 2: Placebo + CRT n=351 Participants Participants received a combination of placebo matched to Debio 1143 along with Chemoradiotherapy(CRT): Radiotherapy +Cisplatin+ placebo matched to Xevinapant (Debio 1143). Participants received 6 cycles of oral solution of placebo matched to Xevinapant once daily from Day 1 to 14, per 3-week cycle in combination with 70 Gray (Gy) of intensity modulated radiation therapy (IMRT) in 35 fractions, 2 Gy/fraction, over 7 weeks, and High-dose cisplatin (100 mg/m2) on Day 2 of a 3-week cycle per 3 cycles(combination therapy period).If high-dose cisplatin 100 mg/m2 was not tolerated after the first dose, participants could be switched to carboplatin (10mg/mL, iv infusion), followed by 3 cycles of monotherapy of placebo matched to Xevinapant from Day 1 to 14, per 3-week cycle (monotherapy period).
Overall Dose Intensity of Cisplatin	32.33 mg/m2/week Standard Deviation 3.053	32.55 mg/m2/week Standard Deviation 2.301

SECONDARY outcome

Timeframe: Cycle 1, 2, 3, 4 5, 6 (each cycle is of 3 weeks) or End of Treatment (Day 134)

Population: The SAF set included all participants who received any dose of any of the study intervention (xevinapant/matched placebo, cisplatin/carboplatin, IMRT).Here "overall number of participants analyzed signified" participants who were evaluable for this outcome measure.

Overall dose intensity of Carboplatin is calculated as the mean of the dose intensities of the individual cycles. This was reported with unit of measure Milligrams per minute per milliliter per week (mg min/mL/week).

Outcome measures

Outcome measures
Measure	Sequence 1: Debio 1143 + CRT n=54 Participants Participants received a combination of Debio 1143 along with Chemoradiotherapy (CRT): Radiotherapy +Cisplatin + Xevinapant (Debio 1143). Participants received 6 cycles of oral solution of Xevinapant at a dose of 200 milligrams per day (mg/day) once daily from Day 1 to 14, per 3-week cycle in combination with 70 Gray (Gy) of intensity modulated radiation therapy (IMRT) in 35 fractions, 2 Gy/fraction, over 7 weeks, and High-dose cisplatin (100 mg/m2) on Day 2 of a 3-week cycle per 3 cycles (combination therapy period). If high-dose cisplatin 100 mg/m2 was not tolerated after the first dose, participants could be switched to carboplatin (10mg/mL, iv infusion), followed by 3 cycles of monotherapy of Xevinapant at a dose of 200 mg/day from Day 1 to 14, per 3-week cycle (monotherapy period).	Sequence 2: Placebo + CRT n=60 Participants Participants received a combination of placebo matched to Debio 1143 along with Chemoradiotherapy(CRT): Radiotherapy +Cisplatin+ placebo matched to Xevinapant (Debio 1143). Participants received 6 cycles of oral solution of placebo matched to Xevinapant once daily from Day 1 to 14, per 3-week cycle in combination with 70 Gray (Gy) of intensity modulated radiation therapy (IMRT) in 35 fractions, 2 Gy/fraction, over 7 weeks, and High-dose cisplatin (100 mg/m2) on Day 2 of a 3-week cycle per 3 cycles(combination therapy period).If high-dose cisplatin 100 mg/m2 was not tolerated after the first dose, participants could be switched to carboplatin (10mg/mL, iv infusion), followed by 3 cycles of monotherapy of placebo matched to Xevinapant from Day 1 to 14, per 3-week cycle (monotherapy period).
Overall Dose Intensity of Carboplatin	1.59 mg min/mL/week Standard Deviation 0.136	1.60 mg min/mL/week Standard Deviation 0.123

SECONDARY outcome

Timeframe: Up to 50 months

Relative dose intensity (RDI) represents the percentage of the amount of a drug actually delivered \[actual dose intensity (DI)\] to the amount planned (planned DI). The purpose of calculating RDI is to evaluate whether the planned DI of an anti-cancer treatment was actually achieved which may suggest the feasibility of planned treatment regimen.

Outcome measures

Outcome measures
Measure	Sequence 1: Debio 1143 + CRT n=363 Participants Participants received a combination of Debio 1143 along with Chemoradiotherapy (CRT): Radiotherapy +Cisplatin + Xevinapant (Debio 1143). Participants received 6 cycles of oral solution of Xevinapant at a dose of 200 milligrams per day (mg/day) once daily from Day 1 to 14, per 3-week cycle in combination with 70 Gray (Gy) of intensity modulated radiation therapy (IMRT) in 35 fractions, 2 Gy/fraction, over 7 weeks, and High-dose cisplatin (100 mg/m2) on Day 2 of a 3-week cycle per 3 cycles (combination therapy period). If high-dose cisplatin 100 mg/m2 was not tolerated after the first dose, participants could be switched to carboplatin (10mg/mL, iv infusion), followed by 3 cycles of monotherapy of Xevinapant at a dose of 200 mg/day from Day 1 to 14, per 3-week cycle (monotherapy period).	Sequence 2: Placebo + CRT n=355 Participants Participants received a combination of placebo matched to Debio 1143 along with Chemoradiotherapy(CRT): Radiotherapy +Cisplatin+ placebo matched to Xevinapant (Debio 1143). Participants received 6 cycles of oral solution of placebo matched to Xevinapant once daily from Day 1 to 14, per 3-week cycle in combination with 70 Gray (Gy) of intensity modulated radiation therapy (IMRT) in 35 fractions, 2 Gy/fraction, over 7 weeks, and High-dose cisplatin (100 mg/m2) on Day 2 of a 3-week cycle per 3 cycles(combination therapy period).If high-dose cisplatin 100 mg/m2 was not tolerated after the first dose, participants could be switched to carboplatin (10mg/mL, iv infusion), followed by 3 cycles of monotherapy of placebo matched to Xevinapant from Day 1 to 14, per 3-week cycle (monotherapy period).
Relative Dose Intensity Xevinapant/matched placebo	92.04 percentage (%) of dose intensity Standard Deviation 13.706	94.92 percentage (%) of dose intensity Standard Deviation 12.372
Relative Dose Intensity Cisplatin	96.98 percentage (%) of dose intensity Standard Deviation 9.159	97.65 percentage (%) of dose intensity Standard Deviation 6.904
Relative Dose Intensity Carboplatin	95.19 percentage (%) of dose intensity Standard Deviation 8.182	96.17 percentage (%) of dose intensity Standard Deviation 7.386

SECONDARY outcome

Timeframe: Up to end of treatment (Day 134)

Number of participants with Treatment Interruption, Treatment Reduction and Treatment Discontinuation was reported.

Outcome measures

Outcome measures
Measure	Sequence 1: Debio 1143 + CRT n=364 Participants Participants received a combination of Debio 1143 along with Chemoradiotherapy (CRT): Radiotherapy +Cisplatin + Xevinapant (Debio 1143). Participants received 6 cycles of oral solution of Xevinapant at a dose of 200 milligrams per day (mg/day) once daily from Day 1 to 14, per 3-week cycle in combination with 70 Gray (Gy) of intensity modulated radiation therapy (IMRT) in 35 fractions, 2 Gy/fraction, over 7 weeks, and High-dose cisplatin (100 mg/m2) on Day 2 of a 3-week cycle per 3 cycles (combination therapy period). If high-dose cisplatin 100 mg/m2 was not tolerated after the first dose, participants could be switched to carboplatin (10mg/mL, iv infusion), followed by 3 cycles of monotherapy of Xevinapant at a dose of 200 mg/day from Day 1 to 14, per 3-week cycle (monotherapy period).	Sequence 2: Placebo + CRT n=356 Participants Participants received a combination of placebo matched to Debio 1143 along with Chemoradiotherapy(CRT): Radiotherapy +Cisplatin+ placebo matched to Xevinapant (Debio 1143). Participants received 6 cycles of oral solution of placebo matched to Xevinapant once daily from Day 1 to 14, per 3-week cycle in combination with 70 Gray (Gy) of intensity modulated radiation therapy (IMRT) in 35 fractions, 2 Gy/fraction, over 7 weeks, and High-dose cisplatin (100 mg/m2) on Day 2 of a 3-week cycle per 3 cycles(combination therapy period).If high-dose cisplatin 100 mg/m2 was not tolerated after the first dose, participants could be switched to carboplatin (10mg/mL, iv infusion), followed by 3 cycles of monotherapy of placebo matched to Xevinapant from Day 1 to 14, per 3-week cycle (monotherapy period).
Number of Participants With Treatment Interruption, Treatment Reduction and Treatment Discontinuation for Xevinapant/ Matched Placebo Treatment Interruption of xevinapant/ matched placebo	206 Participants	147 Participants
Number of Participants With Treatment Interruption, Treatment Reduction and Treatment Discontinuation for Xevinapant/ Matched Placebo Treatment Reduction of xevinapant/ matched placebo	34 Participants	17 Participants
Number of Participants With Treatment Interruption, Treatment Reduction and Treatment Discontinuation for Xevinapant/ Matched Placebo Treatment Discontinuation of xevinapant/ matched placebo	71 Participants	30 Participants

Adverse Events

Sequence 1: Debio 1143 + CRT

Serious events: 194 serious events

Other events: 360 other events

Deaths: 111 deaths

Sequence 2: Placebo + CRT

Serious events: 129 serious events

Other events: 350 other events

Deaths: 93 deaths

Serious adverse events

Other adverse events

Additional Information

Communication Center

Merck Healthcare KGaA, Darmstadt Germany, an affiliate of Merck KGaA, Darmstadt, Germany

Phone: +49-6151-72-5200

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Sequence 1: Debio 1143 + CRT n=363 Participants Participants received a combination of Debio 1143 along with Chemoradiotherapy (CRT): Radiotherapy +Cisplatin + Xevinapant (Debio 1143). Participants received 6 cycles of oral solution of Xevinapant at a dose of 200 milligrams per day (mg/day) once daily from Day 1 to 14, per 3-week cycle in combination with 70 Gray (Gy) of intensity modulated radiation therapy (IMRT) in 35 fractions, 2 Gy/fraction, over 7 weeks, and High-dose cisplatin (100 mg/m2) on Day 2 of a 3-week cycle per 3 cycles (combination therapy period). If high-dose cisplatin 100 mg/m2 was not tolerated after the first dose, participants could be switched to carboplatin (10mg/mL, iv infusion), followed by 3 cycles of monotherapy of Xevinapant at a dose of 200 mg/day from Day 1 to 14, per 3-week cycle (monotherapy period).	Sequence 2: Placebo + CRT n=352 Participants Participants received a combination of placebo matched to Debio 1143 along with Chemoradiotherapy(CRT): Radiotherapy +Cisplatin+ placebo matched to Xevinapant (Debio 1143). Participants received 6 cycles of oral solution of placebo matched to Xevinapant once daily from Day 1 to 14, per 3-week cycle in combination with 70 Gray (Gy) of intensity modulated radiation therapy (IMRT) in 35 fractions, 2 Gy/fraction, over 7 weeks, and High-dose cisplatin (100 mg/m2) on Day 2 of a 3-week cycle per 3 cycles(combination therapy period).If high-dose cisplatin 100 mg/m2 was not tolerated after the first dose, participants could be switched to carboplatin (10mg/mL, iv infusion), followed by 3 cycles of monotherapy of placebo matched to Xevinapant from Day 1 to 14, per 3-week cycle (monotherapy period).
Change From Baseline in Laboratory Parameters: Basophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Lymphocytes: Baseline	1.753 10^9 cells per liter Standard Deviation 0.5734	1.753 10^9 cells per liter Standard Deviation 0.6367
Change From Baseline in Laboratory Parameters: Basophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Monocyte: Max on-treatment change	-0.175 10^9 cells per liter Standard Deviation 0.4050	-0.152 10^9 cells per liter Standard Deviation 0.3870
Change From Baseline in Laboratory Parameters: Basophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Neutrophils: Baseline	5.669 10^9 cells per liter Standard Deviation 2.6589	5.610 10^9 cells per liter Standard Deviation 2.3663
Change From Baseline in Laboratory Parameters: Basophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Platelets: Baseline	292.6 10^9 cells per liter Standard Deviation 104.86	287.7 10^9 cells per liter Standard Deviation 107.38
Change From Baseline in Laboratory Parameters: Basophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Platelets: C3D1	-48.2 10^9 cells per liter Standard Deviation 112.13	-56.5 10^9 cells per liter Standard Deviation 109.52
Change From Baseline in Laboratory Parameters: Basophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Platelets: EOT	-24.8 10^9 cells per liter Standard Deviation 94.59	-38.6 10^9 cells per liter Standard Deviation 87.16
Change From Baseline in Laboratory Parameters: Basophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Platelets: Max on-treatment change	-63.2 10^9 cells per liter Standard Deviation 203.40	-88.7 10^9 cells per liter Standard Deviation 171.61
Change From Baseline in Laboratory Parameters: Basophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Basophils: Baseline	0.052 10^9 cells per liter Standard Deviation 0.0343	0.054 10^9 cells per liter Standard Deviation 0.0367
Change From Baseline in Laboratory Parameters: Basophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Basophils: C3D1	-0.032 10^9 cells per liter Standard Deviation 0.0367	-0.041 10^9 cells per liter Standard Deviation 0.0362
Change From Baseline in Laboratory Parameters: Basophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Basophils: EOT	-0.021 10^9 cells per liter Standard Deviation 0.0367	-0.023 10^9 cells per liter Standard Deviation 0.0312
Change From Baseline in Laboratory Parameters: Basophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Basophil: Max on-treatment change	-0.022 10^9 cells per liter Standard Deviation 0.0673	-0.031 10^9 cells per liter Standard Deviation 0.0618
Change From Baseline in Laboratory Parameters: Basophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Leukocytes: Baseline	8.175 10^9 cells per liter Standard Deviation 2.9656	8.105 10^9 cells per liter Standard Deviation 2.6725
Change From Baseline in Laboratory Parameters: Basophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Leukocytes: C3D1	-4.065 10^9 cells per liter Standard Deviation 3.1244	-4.597 10^9 cells per liter Standard Deviation 2.9352
Change From Baseline in Laboratory Parameters: Basophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Leukocytes: EOT	-2.129 10^9 cells per liter Standard Deviation 3.2074	-2.354 10^9 cells per liter Standard Deviation 2.4137
Change From Baseline in Laboratory Parameters: Basophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Leukocytes: Max on-treatment change	-3.045 10^9 cells per liter Standard Deviation 7.5455	-3.444 10^9 cells per liter Standard Deviation 6.7059
Change From Baseline in Laboratory Parameters: Basophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Lymphocytes: C3D1	-1.168 10^9 cells per liter Standard Deviation 0.5804	-1.251 10^9 cells per liter Standard Deviation 0.5742
Change From Baseline in Laboratory Parameters: Basophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Lymphocytes: EOT	-0.884 10^9 cells per liter Standard Deviation 0.5485	-0.901 10^9 cells per liter Standard Deviation 0.5536
Change From Baseline in Laboratory Parameters: Basophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Lymphocyte: Max on-treatment change	-1.382 10^9 cells per liter Standard Deviation 0.6359	-1.356 10^9 cells per liter Standard Deviation 0.6150
Change From Baseline in Laboratory Parameters: Basophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Monocytes: Baseline	0.518 10^9 cells per liter Standard Deviation 0.2156	0.506 10^9 cells per liter Standard Deviation 0.2072
Change From Baseline in Laboratory Parameters: Basophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Monocytes: C3D1	-0.139 10^9 cells per liter Standard Deviation 0.2389	-0.169 10^9 cells per liter Standard Deviation 0.2063
Change From Baseline in Laboratory Parameters: Basophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Monocytes: EOT	-0.114 10^9 cells per liter Standard Deviation 0.1991	-0.100 10^9 cells per liter Standard Deviation 0.1683
Change From Baseline in Laboratory Parameters: Basophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Neutrophils: C3D1	-2.646 10^9 cells per liter Standard Deviation 2.8532	-3.018 10^9 cells per liter Standard Deviation 2.6744
Change From Baseline in Laboratory Parameters: Basophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Neutrophils: EOT	-1.081 10^9 cells per liter Standard Deviation 2.9287	-1.275 10^9 cells per liter Standard Deviation 2.2696
Change From Baseline in Laboratory Parameters: Basophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Neutrophils: Max on-treatment change	-0.528 10^9 cells per liter Standard Deviation 7.2775	-1.095 10^9 cells per liter Standard Deviation 6.3143

Measure	Sequence 1: Debio 1143 + CRT n=364 Participants Participants received a combination of Debio 1143 along with Chemoradiotherapy (CRT): Radiotherapy +Cisplatin + Xevinapant (Debio 1143). Participants received 6 cycles of oral solution of Xevinapant at a dose of 200 milligrams per day (mg/day) once daily from Day 1 to 14, per 3-week cycle in combination with 70 Gray (Gy) of intensity modulated radiation therapy (IMRT) in 35 fractions, 2 Gy/fraction, over 7 weeks, and High-dose cisplatin (100 mg/m2) on Day 2 of a 3-week cycle per 3 cycles (combination therapy period). If high-dose cisplatin 100 mg/m2 was not tolerated after the first dose, participants could be switched to carboplatin (10mg/mL, iv infusion), followed by 3 cycles of monotherapy of Xevinapant at a dose of 200 mg/day from Day 1 to 14, per 3-week cycle (monotherapy period).	Sequence 2: Placebo + CRT n=356 Participants Participants received a combination of placebo matched to Debio 1143 along with Chemoradiotherapy(CRT): Radiotherapy +Cisplatin+ placebo matched to Xevinapant (Debio 1143). Participants received 6 cycles of oral solution of placebo matched to Xevinapant once daily from Day 1 to 14, per 3-week cycle in combination with 70 Gray (Gy) of intensity modulated radiation therapy (IMRT) in 35 fractions, 2 Gy/fraction, over 7 weeks, and High-dose cisplatin (100 mg/m2) on Day 2 of a 3-week cycle per 3 cycles(combination therapy period).If high-dose cisplatin 100 mg/m2 was not tolerated after the first dose, participants could be switched to carboplatin (10mg/mL, iv infusion), followed by 3 cycles of monotherapy of placebo matched to Xevinapant from Day 1 to 14, per 3-week cycle (monotherapy period).
Change From Baseline in Laboratory Parameters: Alanine Aminotransferase, Alkaline Phosphatase, Amylase, Aspartate Aminotransferase, Lipase Alanine Aminotransferase: Max on-treatment change	55.8 microgram per liter (mcg/L) Standard Deviation 70.73	26.5 microgram per liter (mcg/L) Standard Deviation 45.39
Change From Baseline in Laboratory Parameters: Alanine Aminotransferase, Alkaline Phosphatase, Amylase, Aspartate Aminotransferase, Lipase Alkaline Phosphatase: Baseline	79.3 microgram per liter (mcg/L) Standard Deviation 24.48	78.0 microgram per liter (mcg/L) Standard Deviation 23.20
Change From Baseline in Laboratory Parameters: Alanine Aminotransferase, Alkaline Phosphatase, Amylase, Aspartate Aminotransferase, Lipase Alkaline Phosphatase: C3D1	-0.8 microgram per liter (mcg/L) Standard Deviation 19.94	-1.0 microgram per liter (mcg/L) Standard Deviation 21.89
Change From Baseline in Laboratory Parameters: Alanine Aminotransferase, Alkaline Phosphatase, Amylase, Aspartate Aminotransferase, Lipase Alkaline Phosphatase: Max on-treatment change	12.7 microgram per liter (mcg/L) Standard Deviation 47.38	5.6 microgram per liter (mcg/L) Standard Deviation 49.27
Change From Baseline in Laboratory Parameters: Alanine Aminotransferase, Alkaline Phosphatase, Amylase, Aspartate Aminotransferase, Lipase Aspartate Aminotransferase: Max on-treatment change	20.0 microgram per liter (mcg/L) Standard Deviation 37.35	9.7 microgram per liter (mcg/L) Standard Deviation 25.02
Change From Baseline in Laboratory Parameters: Alanine Aminotransferase, Alkaline Phosphatase, Amylase, Aspartate Aminotransferase, Lipase Lipase: Baseline	35.4 microgram per liter (mcg/L) Standard Deviation 48.01	29.8 microgram per liter (mcg/L) Standard Deviation 19.37
Change From Baseline in Laboratory Parameters: Alanine Aminotransferase, Alkaline Phosphatase, Amylase, Aspartate Aminotransferase, Lipase Lipase: C3D1	-4.0 microgram per liter (mcg/L) Standard Deviation 39.69	-4.0 microgram per liter (mcg/L) Standard Deviation 23.64
Change From Baseline in Laboratory Parameters: Alanine Aminotransferase, Alkaline Phosphatase, Amylase, Aspartate Aminotransferase, Lipase Lipase: EOT	-1.8 microgram per liter (mcg/L) Standard Deviation 47.38	-1.0 microgram per liter (mcg/L) Standard Deviation 21.69
Change From Baseline in Laboratory Parameters: Alanine Aminotransferase, Alkaline Phosphatase, Amylase, Aspartate Aminotransferase, Lipase Lipase: Max on-treatment change	87.3 microgram per liter (mcg/L) Standard Deviation 196.87	25.0 microgram per liter (mcg/L) Standard Deviation 60.54
Change From Baseline in Laboratory Parameters: Alanine Aminotransferase, Alkaline Phosphatase, Amylase, Aspartate Aminotransferase, Lipase Amylase: Baseline	70.0 microgram per liter (mcg/L) Standard Deviation 42.81	67.8 microgram per liter (mcg/L) Standard Deviation 61.61
Change From Baseline in Laboratory Parameters: Alanine Aminotransferase, Alkaline Phosphatase, Amylase, Aspartate Aminotransferase, Lipase Amylase: C3D1	-14.0 microgram per liter (mcg/L) Standard Deviation 38.07	-14.0 microgram per liter (mcg/L) Standard Deviation 32.85
Change From Baseline in Laboratory Parameters: Alanine Aminotransferase, Alkaline Phosphatase, Amylase, Aspartate Aminotransferase, Lipase Amylase: EOT	-13.5 microgram per liter (mcg/L) Standard Deviation 40.51	-13.5 microgram per liter (mcg/L) Standard Deviation 33.79
Change From Baseline in Laboratory Parameters: Alanine Aminotransferase, Alkaline Phosphatase, Amylase, Aspartate Aminotransferase, Lipase Amylase: Max on-treatment change	125.8 microgram per liter (mcg/L) Standard Deviation 205.22	60.4 microgram per liter (mcg/L) Standard Deviation 119.29
Change From Baseline in Laboratory Parameters: Alanine Aminotransferase, Alkaline Phosphatase, Amylase, Aspartate Aminotransferase, Lipase Aspartate Aminotransferase: Baseline	19.8 microgram per liter (mcg/L) Standard Deviation 11.10	19.8 microgram per liter (mcg/L) Standard Deviation 8.31
Change From Baseline in Laboratory Parameters: Alanine Aminotransferase, Alkaline Phosphatase, Amylase, Aspartate Aminotransferase, Lipase Aspartate Aminotransferase: C3D1	-2.4 microgram per liter (mcg/L) Standard Deviation 12.30	-3.5 microgram per liter (mcg/L) Standard Deviation 8.63
Change From Baseline in Laboratory Parameters: Alanine Aminotransferase, Alkaline Phosphatase, Amylase, Aspartate Aminotransferase, Lipase Aspartate Aminotransferase: EOT	0.4 microgram per liter (mcg/L) Standard Deviation 19.01	0.9 microgram per liter (mcg/L) Standard Deviation 18.80
Change From Baseline in Laboratory Parameters: Alanine Aminotransferase, Alkaline Phosphatase, Amylase, Aspartate Aminotransferase, Lipase Alanine Aminotransferase: Baseline	18.9 microgram per liter (mcg/L) Standard Deviation 12.10	19.4 microgram per liter (mcg/L) Standard Deviation 12.66
Change From Baseline in Laboratory Parameters: Alanine Aminotransferase, Alkaline Phosphatase, Amylase, Aspartate Aminotransferase, Lipase Alanine Aminotransferase: C3D1	0.5 microgram per liter (mcg/L) Standard Deviation 16.77	-4.6 microgram per liter (mcg/L) Standard Deviation 13.53
Change From Baseline in Laboratory Parameters: Alanine Aminotransferase, Alkaline Phosphatase, Amylase, Aspartate Aminotransferase, Lipase Alanine Aminotransferase: EOT	-2.0 microgram per liter (mcg/L) Standard Deviation 18.25	-3.4 microgram per liter (mcg/L) Standard Deviation 15.87
Change From Baseline in Laboratory Parameters: Alanine Aminotransferase, Alkaline Phosphatase, Amylase, Aspartate Aminotransferase, Lipase Alkaline Phosphatase: EOT	-2.2 microgram per liter (mcg/L) Standard Deviation 28.14	-5.6 microgram per liter (mcg/L) Standard Deviation 18.79

Measure	Sequence 1: Debio 1143 + CRT n=364 Participants Participants received a combination of Debio 1143 along with Chemoradiotherapy (CRT): Radiotherapy +Cisplatin + Xevinapant (Debio 1143). Participants received 6 cycles of oral solution of Xevinapant at a dose of 200 milligrams per day (mg/day) once daily from Day 1 to 14, per 3-week cycle in combination with 70 Gray (Gy) of intensity modulated radiation therapy (IMRT) in 35 fractions, 2 Gy/fraction, over 7 weeks, and High-dose cisplatin (100 mg/m2) on Day 2 of a 3-week cycle per 3 cycles (combination therapy period). If high-dose cisplatin 100 mg/m2 was not tolerated after the first dose, participants could be switched to carboplatin (10mg/mL, iv infusion), followed by 3 cycles of monotherapy of Xevinapant at a dose of 200 mg/day from Day 1 to 14, per 3-week cycle (monotherapy period).	Sequence 2: Placebo + CRT n=356 Participants Participants received a combination of placebo matched to Debio 1143 along with Chemoradiotherapy(CRT): Radiotherapy +Cisplatin+ placebo matched to Xevinapant (Debio 1143). Participants received 6 cycles of oral solution of placebo matched to Xevinapant once daily from Day 1 to 14, per 3-week cycle in combination with 70 Gray (Gy) of intensity modulated radiation therapy (IMRT) in 35 fractions, 2 Gy/fraction, over 7 weeks, and High-dose cisplatin (100 mg/m2) on Day 2 of a 3-week cycle per 3 cycles(combination therapy period).If high-dose cisplatin 100 mg/m2 was not tolerated after the first dose, participants could be switched to carboplatin (10mg/mL, iv infusion), followed by 3 cycles of monotherapy of placebo matched to Xevinapant from Day 1 to 14, per 3-week cycle (monotherapy period).
Change From Baseline in Laboratory Parameters: Bilirubin, Creatinine, Direct Bilirubin, Urate Bilirubin: Baseline	7.4 micromole per liter (mcmol/L) Standard Deviation 4.03	7.8 micromole per liter (mcmol/L) Standard Deviation 4.06
Change From Baseline in Laboratory Parameters: Bilirubin, Creatinine, Direct Bilirubin, Urate Creatinine: EOT	17.660 micromole per liter (mcmol/L) Standard Deviation 49.3934	16.243 micromole per liter (mcmol/L) Standard Deviation 32.1216
Change From Baseline in Laboratory Parameters: Bilirubin, Creatinine, Direct Bilirubin, Urate Creatinine: Max on-treatment change	292.808 micromole per liter (mcmol/L) Standard Deviation 4199.9623	360.521 micromole per liter (mcmol/L) Standard Deviation 5664.5213
Change From Baseline in Laboratory Parameters: Bilirubin, Creatinine, Direct Bilirubin, Urate Direct Bilirubin: Baseline	4.8 micromole per liter (mcmol/L) Standard Deviation 0.75	5.6 micromole per liter (mcmol/L) Standard Deviation 1.33
Change From Baseline in Laboratory Parameters: Bilirubin, Creatinine, Direct Bilirubin, Urate Direct Bilirubin: C3D1	—	3.0 micromole per liter (mcmol/L) Standard Deviation NA Due to the presence of only a single data value for one participant, standard deviation could not be computed.
Change From Baseline in Laboratory Parameters: Bilirubin, Creatinine, Direct Bilirubin, Urate Direct Bilirubin: EOT	—	0.0 micromole per liter (mcmol/L) Standard Deviation 1.41
Change From Baseline in Laboratory Parameters: Bilirubin, Creatinine, Direct Bilirubin, Urate Direct Bilirubin: Max on-treatment change	2.5 micromole per liter (mcmol/L) Standard Deviation 2.12	1.0 micromole per liter (mcmol/L) Standard Deviation 2.14
Change From Baseline in Laboratory Parameters: Bilirubin, Creatinine, Direct Bilirubin, Urate Urate: Baseline	303.1 micromole per liter (mcmol/L) Standard Deviation 79.62	305.9 micromole per liter (mcmol/L) Standard Deviation 82.79
Change From Baseline in Laboratory Parameters: Bilirubin, Creatinine, Direct Bilirubin, Urate Bilirubin: C3D1	-1.8 micromole per liter (mcmol/L) Standard Deviation 3.74	-1.5 micromole per liter (mcmol/L) Standard Deviation 3.68
Change From Baseline in Laboratory Parameters: Bilirubin, Creatinine, Direct Bilirubin, Urate Bilirubin: EOT	-2.0 micromole per liter (mcmol/L) Standard Deviation 3.85	-1.3 micromole per liter (mcmol/L) Standard Deviation 3.52
Change From Baseline in Laboratory Parameters: Bilirubin, Creatinine, Direct Bilirubin, Urate Bilirubin: Max on-treatment change	1.1 micromole per liter (mcmol/L) Standard Deviation 7.49	0.1 micromole per liter (mcmol/L) Standard Deviation 6.83
Change From Baseline in Laboratory Parameters: Bilirubin, Creatinine, Direct Bilirubin, Urate Creatinine: Baseline	67.884 micromole per liter (mcmol/L) Standard Deviation 15.1427	70.612 micromole per liter (mcmol/L) Standard Deviation 15.3405
Change From Baseline in Laboratory Parameters: Bilirubin, Creatinine, Direct Bilirubin, Urate Creatinine: C3D1	11.771 micromole per liter (mcmol/L) Standard Deviation 27.4012	11.740 micromole per liter (mcmol/L) Standard Deviation 26.2545
Change From Baseline in Laboratory Parameters: Bilirubin, Creatinine, Direct Bilirubin, Urate Urate: C3D1	-25.4 micromole per liter (mcmol/L) Standard Deviation 90.93	-21.5 micromole per liter (mcmol/L) Standard Deviation 91.07
Change From Baseline in Laboratory Parameters: Bilirubin, Creatinine, Direct Bilirubin, Urate Urate: EOT	25.9 micromole per liter (mcmol/L) Standard Deviation 85.01	33.1 micromole per liter (mcmol/L) Standard Deviation 80.07
Change From Baseline in Laboratory Parameters: Bilirubin, Creatinine, Direct Bilirubin, Urate Urate: Max on-treatment change	1.2 micromole per liter (mcmol/L) Standard Deviation 140.44	12.7 micromole per liter (mcmol/L) Standard Deviation 137.74

Measure	Sequence 1: Debio 1143 + CRT n=364 Participants Participants received a combination of Debio 1143 along with Chemoradiotherapy (CRT): Radiotherapy +Cisplatin + Xevinapant (Debio 1143). Participants received 6 cycles of oral solution of Xevinapant at a dose of 200 milligrams per day (mg/day) once daily from Day 1 to 14, per 3-week cycle in combination with 70 Gray (Gy) of intensity modulated radiation therapy (IMRT) in 35 fractions, 2 Gy/fraction, over 7 weeks, and High-dose cisplatin (100 mg/m2) on Day 2 of a 3-week cycle per 3 cycles (combination therapy period). If high-dose cisplatin 100 mg/m2 was not tolerated after the first dose, participants could be switched to carboplatin (10mg/mL, iv infusion), followed by 3 cycles of monotherapy of Xevinapant at a dose of 200 mg/day from Day 1 to 14, per 3-week cycle (monotherapy period).	Sequence 2: Placebo + CRT n=356 Participants Participants received a combination of placebo matched to Debio 1143 along with Chemoradiotherapy(CRT): Radiotherapy +Cisplatin+ placebo matched to Xevinapant (Debio 1143). Participants received 6 cycles of oral solution of placebo matched to Xevinapant once daily from Day 1 to 14, per 3-week cycle in combination with 70 Gray (Gy) of intensity modulated radiation therapy (IMRT) in 35 fractions, 2 Gy/fraction, over 7 weeks, and High-dose cisplatin (100 mg/m2) on Day 2 of a 3-week cycle per 3 cycles(combination therapy period).If high-dose cisplatin 100 mg/m2 was not tolerated after the first dose, participants could be switched to carboplatin (10mg/mL, iv infusion), followed by 3 cycles of monotherapy of placebo matched to Xevinapant from Day 1 to 14, per 3-week cycle (monotherapy period).
Change From Baseline in Laboratory Parameters: Calcium, Magnesium, Potassium, Sodium, Urea Sodium: Baseline	139.3333 millimoles per liter (mmol/L) Standard Deviation 2.72935	139.1798 millimoles per liter (mmol/L) Standard Deviation 3.19705
Change From Baseline in Laboratory Parameters: Calcium, Magnesium, Potassium, Sodium, Urea Sodium: C3D1	-2.0828 millimoles per liter (mmol/L) Standard Deviation 3.96368	-1.5527 millimoles per liter (mmol/L) Standard Deviation 3.73110
Change From Baseline in Laboratory Parameters: Calcium, Magnesium, Potassium, Sodium, Urea Sodium: EOT	-0.9510 millimoles per liter (mmol/L) Standard Deviation 3.53728	-0.9521 millimoles per liter (mmol/L) Standard Deviation 3.71944
Change From Baseline in Laboratory Parameters: Calcium, Magnesium, Potassium, Sodium, Urea Sodium: Max on-treatment change	-4.7482 millimoles per liter (mmol/L) Standard Deviation 9.86512	-4.6627 millimoles per liter (mmol/L) Standard Deviation 14.14911
Change From Baseline in Laboratory Parameters: Calcium, Magnesium, Potassium, Sodium, Urea Urea: C3D1	1.89 millimoles per liter (mmol/L) Standard Deviation 3.302	1.87 millimoles per liter (mmol/L) Standard Deviation 3.961
Change From Baseline in Laboratory Parameters: Calcium, Magnesium, Potassium, Sodium, Urea Urea: EOT	1.73 millimoles per liter (mmol/L) Standard Deviation 3.266	1.40 millimoles per liter (mmol/L) Standard Deviation 2.922
Change From Baseline in Laboratory Parameters: Calcium, Magnesium, Potassium, Sodium, Urea Urea: Max on-treatment change	8.51 millimoles per liter (mmol/L) Standard Deviation 7.226	6.18 millimoles per liter (mmol/L) Standard Deviation 6.110
Change From Baseline in Laboratory Parameters: Calcium, Magnesium, Potassium, Sodium, Urea Calcium: Baseline	2.4065 millimoles per liter (mmol/L) Standard Deviation 0.14050	2.4043 millimoles per liter (mmol/L) Standard Deviation 0.11777
Change From Baseline in Laboratory Parameters: Calcium, Magnesium, Potassium, Sodium, Urea Calcium: C3D1	-0.1054 millimoles per liter (mmol/L) Standard Deviation 0.16830	-0.0574 millimoles per liter (mmol/L) Standard Deviation 0.12989
Change From Baseline in Laboratory Parameters: Calcium, Magnesium, Potassium, Sodium, Urea Calcium: EOT	0.0006 millimoles per liter (mmol/L) Standard Deviation 0.15586	0.0136 millimoles per liter (mmol/L) Standard Deviation 0.12258
Change From Baseline in Laboratory Parameters: Calcium, Magnesium, Potassium, Sodium, Urea Calcium: Max on-treatment change	-0.1182 millimoles per liter (mmol/L) Standard Deviation 0.64226	-0.0575 millimoles per liter (mmol/L) Standard Deviation 0.63941
Change From Baseline in Laboratory Parameters: Calcium, Magnesium, Potassium, Sodium, Urea Magnesium: Baseline	0.8731 millimoles per liter (mmol/L) Standard Deviation 0.08816	0.8718 millimoles per liter (mmol/L) Standard Deviation 0.08800
Change From Baseline in Laboratory Parameters: Calcium, Magnesium, Potassium, Sodium, Urea Magnesium: C3D1	-0.0871 millimoles per liter (mmol/L) Standard Deviation 0.11743	-0.0719 millimoles per liter (mmol/L) Standard Deviation 0.11889
Change From Baseline in Laboratory Parameters: Calcium, Magnesium, Potassium, Sodium, Urea Magnesium: EOT	-0.0588 millimoles per liter (mmol/L) Standard Deviation 0.10612	-0.0372 millimoles per liter (mmol/L) Standard Deviation 0.08725
Change From Baseline in Laboratory Parameters: Calcium, Magnesium, Potassium, Sodium, Urea Magnesium: Max on-treatment change	-0.1231 millimoles per liter (mmol/L) Standard Deviation 0.21711	-0.0860 millimoles per liter (mmol/L) Standard Deviation 0.21948
Change From Baseline in Laboratory Parameters: Calcium, Magnesium, Potassium, Sodium, Urea Potassium: Baseline	4.4270 millimoles per liter (mmol/L) Standard Deviation 0.41610	4.4534 millimoles per liter (mmol/L) Standard Deviation 0.44584
Change From Baseline in Laboratory Parameters: Calcium, Magnesium, Potassium, Sodium, Urea Potassium: C3D1	-0.1226 millimoles per liter (mmol/L) Standard Deviation 0.60007	-0.0877 millimoles per liter (mmol/L) Standard Deviation 0.58424
Change From Baseline in Laboratory Parameters: Calcium, Magnesium, Potassium, Sodium, Urea Potassium: EOT	-0.0374 millimoles per liter (mmol/L) Standard Deviation 0.52898	0.0170 millimoles per liter (mmol/L) Standard Deviation 0.58221
Change From Baseline in Laboratory Parameters: Calcium, Magnesium, Potassium, Sodium, Urea Potassium: Max on-treatment change	-0.2845 millimoles per liter (mmol/L) Standard Deviation 1.13356	-0.2551 millimoles per liter (mmol/L) Standard Deviation 1.14282
Change From Baseline in Laboratory Parameters: Calcium, Magnesium, Potassium, Sodium, Urea Urea: Baseline	5.22 millimoles per liter (mmol/L) Standard Deviation 1.885	5.23 millimoles per liter (mmol/L) Standard Deviation 2.068